Medical fluid delivery system and method relating to the same

ABSTRACT

A medical fluid delivery system for the use in the delivery of medical fluids. The medical fluid delivery system may include a pumping system, a disposable medical fluid line set and a valve operating system. The disposable tubing line set may include valves adapted to interface with the valve operating system. The valve operating system may be adapted to operate only selected valves using a single drive means. The pumping system may be operated over a wide range of medical fluid delivery rates by employing a bi-directional drive member and a transmission interfaced with the drive member and a pump.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of prior U.S. patent application Ser.No. 11/050,031 filed Feb. 2, 2005, entitled “MEDICAL FLUID DELIVERYSYSTEM AND METHOD RELATING TO THE SAME”, which is a continuation-in-partof PCT Patent Application Serial No. US2004/023799 filed Jul. 23, 2004,entitled “DRIVE MOTOR TRANSMISSION SYSTEM”, which claims priority toU.S. Provisional Patent Application Ser. No. 60/489,401 filed Jul. 23,2003, entitled “ELECTRIC DRIVE MOTOR TRANSMISSION SYSTEM”. Theabove-referenced patent applications are incorporated herein byreference as if their contents were set forth below in full.

FIELD OF THE INVENTION

This invention is generally directed to a drive motor system whichoperates over a wide range of speeds and torques through a novelarrangement of motion transfer members (e.g., gears and clutches), abi-directional drive member (e.g., a bi-directional motor), which can bedriven bi-directionally, and a transmission. In a particularapplication, the invention is directed to fluid pumping with a drivemotor system that utilizes a bi-directional motor to achieve a range offluid movement rates and torques. More particularly, the drive motorsystem is particularly suited for implementation in a medical fluiddelivery system and in methods relating to the same.

The invention is further directed to a fluid pumping system withmultiple inlet input lines and a mechanism (e.g., a valve operatingsystem) to selectively open input fluid line valves in any sequence todeliver said fluid to a single fluid output line. In particular, thefluid pumping system and valve operating system may be implemented in amedical fluid delivery system, which may comprise a disposable medicalfluid line set. In this regard, a valve operating system may be employedto operate valves utilized in a disposable medical fluid line set. Thedrive motor system, valves and valve operating systems described by thepresent invention may be particularly adapted for use with anintravenous infusion pump employable in a medical fluid delivery system.

BACKGROUND OF THE INVENTION

Motors are used to provide motive forces for many applications. In someapplications, a single device is tasked with both rapid, low precisionmovement during a first activity, and slow, precisely controlledmovement during a second activity. In order to achieve both types ofmovement, many devices must use two motors, one for the fast movementand another for the slow movement, thus increasing the cost, size andweight of the device. Other options include the use of stepper motors,which are able to develop significant slow motor speed torque andprecise rotational control. However, stepper motors have numerousdisadvantages, including high cost, the need for relatively complicatedcontrol circuitry, large size, large weight and high power requirements.

The disadvantages of presently available motor systems are particularlyproblematic in medical infusion pump systems. Intravenous infusiontherapy is prescribed where it is desirable to administer medicationsand other fluids directly into the circulatory system of a patient.Medical infusion pumps have typically employed stepper motors to providerotational motive force, and thus are limited by the disadvantages of astepper motor as listed above. Further, for many clinical procedures itis desirable to administer several medical fluids to a patientsimultaneously, thus requiring multiple independent gravity flowcontrollers and/or multiple independent electronic pumps. The use ofmultiple independent controllers or pumps, however, is disadvantageousfor many reasons, including: the increased possibility of infectionoccasioned by multiple IV venipuncture; the increased discomfort to thepatient, the considerable labor and time required for administeringmultiple IVs and setting up multiple controllers/pumps; the increasedclutter around the patient; the comparatively high cost of procuring andmaintaining several pumps; and the comparatively high cost incurred inmaintaining an inventory of tubes required by each of the different pumptypes.

Past attempts to overcome some of these above-described difficultieshave resulted in devices utilizing multiple valves, such as described inU.S. Pat. No. 4,696,671 to Epstein et al. Epstein et al. disclose asterile, disposable cassette containing fluid input and output lines andchambers, wherein the cassette is inserted into a pumping mechanism suchthat plungers from the pump mechanism engage and close the valves of thecassette. Thus, Epstein et al. disclose a system where the valves of thecassette are biased to an open state when not engaged by a pumpmechanism. This arrangement may result in unintentional fluid flow to apatient when the valve set is mistakenly removed from or incorrectlyaligned within the pump unit. The valves of Epstein et al. must also beopened sequentially in order to reach the valve of interest. Therefore,an additional valve and independent motive force for the valve isrequired to prohibit flow during a period in which the unintended valveis open, such as by using a third motor. In some circumstances,operation of valves in accordance with the teachings of Epstein et al.is not desirable due to the resultant fluid interactions or fluiddamage, such as cell damage to blood cells.

SUMMARY OF THE INVENTION

In view of the foregoing, it is an object of the invention to provide adrive motor system that includes a bi-directional drive member (e.g. abi-directional motor), a first motion transfer member (e.g. a first gearand a first one-way clutch), where the first motion transfer member isin mechanical contact with an output shaft such that when thebi-directional drive member (e.g. bi-directional drive motor) is turnedin a first direction, a first output is produced. Also provided in sucha drive motor system is a second motion transfer member (e.g. a secondgear, a second one-way clutch and at least one additional transmissiongear) in mechanical contact with the bi-directional drive member (e.g.motor), and the output shaft such that when the bi-directional drivemember (e.g. bi-directional motor) is turned in a second direction, asecond output is produced. More particularly, it is an object of theinvention to provide a medical fluid delivery system that comprises theabove drive motor system.

A further object of the invention is a method of providing a device witha wide range of motor speeds and torques by providing a drive motorsystem, where the first and second motion transfer members both drivethe output shaft in the same one direction, and at varying speeds, inresponse to the first and second outputs of the bi-directional motor,respectively. More particularly, it is an object of the invention toutilize a medical fluid delivery system that comprises the above drivemotor system for delivering medical fluids over a wide range of flowrates.

A further object of the invention is a fluid pump and a method ofpumping fluids using a fluid pump, emphasizing a drive motor system anddrive method, as described above. Such a fluid pump may employadditional elements of the present invention, including a rotary orlinear pump head, a plurality of fluid input lines in fluid connectionwith a manifold (which may be in fluid connection with a fluid outputline), a plurality of pinch valves which may receive the fluid inputlines, a valve operating system, a pressure measurement system, a powersupply, a computer processor and control system, and a housing adaptedto receive such elements. More particularly, it is an object of theinvention to provide a medical fluid delivery system that comprises oneor more of the above fluid pump, drive motor system, a rotary or linearpump head, a plurality of fluid input lines, a manifold, a fluid outputline, a plurality of pinch valves, a valve operating system, a pressuremeasurement system, a power supply, a computer processor and controlsystem, and/or a housing.

It is a further object of the invention to provide an improved pinchvalve, where the improvements include a biasing means for forcing firstand second elongated members in at least a first direction about a pivotpoint to a pinching position (e.g., a normally-closed position). Theimprovements may further comprise at least one rib and at least onevalley. In one approach, the at least one rib and at least one valleyare designed to form a portion of a fluid line into a serpentine shape.The pinch valve may further include at least one adaptation that allowsthe pinch valve to receive or be received by a valve operating system.Such at least one adaptation may be designed to matably receive andengaged another adaptation (e.g., a male-female arrangement), such aswith the use of slots or pins. More particularly, it is an object of theinvention to provide a medical fluid delivery system that comprises theabove pinch valve. In one aspect, a medical fluid line set is arrangedwith the pinch valve and within the medical fluid delivery system suchthat when one or more medical fluid delivery line is removed, eitherintentionally or unintentionally, fluid flow is substantially orcompletely occluded through the correspondingly removed medical fluiddelivery line(s).

It is a further object of the invention to provide a valve operatingsystem and method for opening and closing pinch valves. Such a systemmay include a central drive member (e.g. a drive motor and a centraldrive gear in mechanical contact with the output shaft of the motor), aplurality of activation members (e.g. mutilated gears) in mechanicalcontact with the central drive member, and a plurality of valveinterface members (e.g. actuator gears, actuator clutches and valveactuators) in mechanical contact with the valve activation members (e.g.mutilated gears). In one aspect, the valve actuators are adapted tointerface with (e.g., matably receive and/or engage) the pinch valves,such that rotation of the valve actuators may cause the pinch valve toat least partially open or close. More particularly, it is an object ofthe invention to provide a medical fluid delivery system that comprisesthe above valve operating system.

In conjunction therewith, a medical fluid delivery system is providedwhich may implement various aspects of the present invention. It isinitially noted that such systems may provide for the delivery of amedical fluid to a patient (e.g., a human or animal) or a receptacle. Assuch, it will be appreciated that whether reference is made to a patientor receptacle in regards to the various aspect, approaches,applications, embodiments and the like described herein, such areference is equally applicable to either a patient or receptacle, andis not meant to limit such application of the medical fluid deliverysystem.

In that regard, the medical fluid delivery system may comprise a medicalfluid line set comprising a plurality of medical fluid delivery linesreceived by (e.g., interconnected with) a corresponding plurality ofpinch valves. The medical fluid line set may be further interfaced witha valve operating system that enables the selective opening of onlycertain valves of the plurality of pinch valves. The valve operatingsystem may include a plurality of valve actuators, where each of thevalve actuators is adapted to matably receive and engage the valves suchthat rotation of the valve actuator causes the pinch valve to at leastpartially open or close.

The valve operating system may further comprise a valve statusdetermination system for determining the positions of each of the valveactuators associated with a plurality of pinch valves, wherein thesystem may then determine and take an action in accordance with an inputthereto. For example, the valve operating system may receive an inputrelating to changing from delivering a first medical fluid to a patientto delivering a second medical fluid to a patient. In this regard, thevalve operating system, in conjunction with the valve statusdetermination system, may be operable to determine which valveactuator(s) is/are actuated and de-actuate such valve actuator(s).Further, the valve operating system may be operable to determine whichvalve actuator(s) is/are associated with delivery of the second medicalfluid and actuate such valve actuator(s). In one aspect, the valveoperating system is operable to actuate the valve actuator(s) associatedwith the delivery of the second medical fluid without actuating anyother valve actuator.

In one aspect, an inventive medical fluid delivery system may utilize asingle pump (e.g., such as an infusion pump or a compounding pump) inconjunction with the drive motor system to deliver medical fluids over awide-range of flow rates, which in the context of medical applicationsis applicable to an infusion pump. In this regard, the medical fluiddelivery system may include a pumping system, which may include a drivemotor, a bi-directional drive member (e.g., a bi-directional motor and amotor gear), a first motion transfer member (e.g., a first gear and afirst one-way clutch) in mechanical contact with the bidirectional drivemember and a pump drive member (e.g., an output shaft), where moving thebi-directional drive member in a first direction produces a firstoutput. The first output moves at least a portion of the pump drivemember, via the first motion transfer member, in one direction at afirst speed. The pumping system may also include a second motiontransfer member (e.g., a second gear, a second one-way clutch and atleast one additional transmission gear) in mechanical contact with thebi-directional drive member, where moving the bi-directional drivemember in a second direction produces a second output. The second outputmoves at least a portion of the pump drive member, via the second motiontransfer member, in the same one direction at a second speed.

In one approach, the bi-directional drive member may be moved at a widerange of speeds (e.g., by changing the supplied current and/or voltageto electric bi-directional drive motor) and/or operated at intermittenttimes in both the first and second directions, thereby enabling thefirst and second outputs to vary in response thereto. Such speedvariation and/or intermittent pump operation, thus, enables a pumpinterfaced with such bi-directional drive member to deliver medicalfluids over a wide range of flow rates in corresponding relation to thefirst and second outputs.

As will be appreciated, the first motion transfer members may be sized,and arranged with the bi-directional drive member, such that theircorresponding first and second outputs relate to different medical flowrate ranges. In this regard, the bi-directional drive motor may beoperable within a predetermined range. In relation thereto, thebi-directional drive member may selectively provide the first and secondoutputs within first and second predetermined operating ranges,respectively. In one embodiment, the first predetermined operating rangecorresponds to a first medical fluid delivery rate range, and the secondpredetermined operating range corresponds to a second medical fluiddelivery rate range. In one particular aspect, the first and secondmedical fluid delivery rate ranges are at least partiallynon-overlapping. In another aspect, the first and second medical fluiddelivery rate ranges are non-overlapping.

Further in this regard, each of the first and second medical fluiddelivery rate ranges may have maximum and minimum flow rates associatedtherewith. In one embodiment, the first medical fluid delivery raterange has a maximum flow rate 2000 ml per minute, more particularly 1000ml per minute, and a minimum flow rate of 1 ml per minute, moreparticularly 5 ml per minute, even more particularly 10 ml per minute.In one embodiment, the second medical fluid delivery rate range has amaximum flow rate of 100 ml per minute, more particularly 50 ml perminute, and a minimum flow rate of 0.1 ml per minute, more particularly1 ml per minute.

In one approach, the first and second motion transfer members are chosenand arranged with the bi-directional drive member and pump drive membersuch that at least one, and in some instances each, is capable ofchanging the fluid delivery rate of the pump by a factor of up to 1000×(e.g., 2×, 3×, 4×, 5×, 10×, 25×, 50×, 75×, 10×, 250×, 500×, 750× and1000×) in corresponding relation to speed changes and/or changes in timeof operation (e.g., more or less intermittent or continuous) of thebi-directional drive member. In another approach, the first and secondmotion transfer members are chosen and arranged with the bi-directionaldrive member and pump drive member such that the first outputcorresponds to a maximum first medical fluid delivery rate that is up to1000 times greater (e.g., 2×, 5×, 10×, 20×, 50×, 100×, 250×, 500× and1000×) than a second maximum medical fluid delivery rate, where thesecond maximum fluid delivery rate corresponds to the second output.

In another approach, the drive motor system of the present invention maybe used as a compounding pump. In this application, the multi-fluidcapability described in the infusion pump above would be used tocompound two or more fluids. Medical compounding pumps typically combinetwo or more fluids to be administered to a patient. However, thesesystems are not connected to the patient, and are not used foradministration purposes, but are generally used to delivery a medicalfluid to a receptacle (e.g., in pharmaceutical applications).Non-medical compounding applications include systems for mixing two-partadhesives, foams and other fluid materials that need to be combined atthe point-of-use. The drive motor system of the present invention may beused to continuously deliver two or more compounding fluids, withprecise concentrations.

One of skill in the art would also readily understand that thetransmission of the motor drive system of the present invention has manyapplications other than the infusion and/or compounding pump utilized todescribe medical fluid delivery system herein. For example, thetransmission could be used in a fluid sampling device, such as a deviceused in a fashion opposite to the described infusion pump in which asingle inlet tube accepts a fluid and places fluid samples in multiplecontainers (e.g., in pharmaceutical applications). A further exampleincludes the use of the transmission in mechanical actuators such asthose used in aircraft, spacecraft, robotics, or assembly equipment. Inorder to move a large mass with precision and speed, the transmission ofthe present invention may be used. Rotation of a motor in a firstdirection in conjunction with the transmission of the present inventioncreates high speed to actuate the majority of the motion rapidly.Rotation of a motor in a second direction in conjunction with thetransmission of the present invention leads to slower more precisemotion. In an assembly line, for example, an automated arm may quicklyrotate to retrieve a part from storage and bring it to the point ofassembly. There, a motor may be rotated in a second direction inconjunction with the transmission of the present invention to allow forprecise positioning of the part on the item being assembled.

Another embodiment for the transmission of the present invention is asimple, low cost drive mechanism. A motor may be combined with atwo-speed transmission of the present invention to provide initialmotion via the lowest gear ratio and the most mechanical advantage in afirst motor direction, allowing an object to start moving from acomplete stop. Switching to a second motor direction allows for faster,sustained motion via a gain in rotational speed created by a lessermechanical advantage (i.e., higher gear ratio). Exemplary uses of such atwo-speed drive transmission and motor include providing motive forcefor toys, scooters, cars, aircraft, boats, centrifuges, computer harddrives, CD-ROM drives and the like.

In another embodiment, the transmission of the present invention may beused in a human-powered vehicle, such as a bicycle. In such a system,pedaling in one direction engages the lowest gear ratio in order toallow the cyclist to easily begin moving from a complete stop. Pedalingin the opposite direction engages the higher gear ratio in order tomaintain or increase speed. Additionally, a geared interface and amechanism for engaging and disengaging the geared interface may be usedwith the two-speed bicycle transmission system to allow the cyclist topedal continuously in one direction while still being able to alternatebetween the high and low gear ratio.

In order to overcome the disadvantages incumbent in the use of priormotors (e.g., stepper motors), the present invention describes a novelinfusion pump mechanism in which a relatively inexpensive andlightweight motor may be driven bi-directionally to achieve a dual speedand torque range system suitable for operating a medical fluid pump overat least two flow rate ranges. This pump mechanism enables the design ofa small and lightweight drive motor system capable of operating longterm on batteries over wide flow ranges.

The present application hereinafter describes an inventive drive motorsystem, valve operating system, fluid line set and pinch valve in thecontext of a medical fluid delivery system. One of skill in the art willreadily understand that the drive motor system described in relation toa medical fluid delivery system could be readily utilized as the motiveforce in any number of devices, particularly in devices which require awide range of speeds and torques, including but not limited to, medicaland non-medical compounding pumps, robotics, electronics and computers,linear and rotary actuators, automated laboratory instruments,spacecraft actuators, aircraft actuators, machine tools such as lathes,milling machines and presses, bicycle drive systems, automotive drivesystems, cable drive systems, valve closure devices, centrifuges, highspeed devices, fans, and energy storage devices.

In one embodiment, the medical fluid delivery system includes a pumpingsystem. The pumping system may include a bi-direction drive member (e.g.a bi-directional drive motor having a motor shaft and a motor gearattached to the motor shaft), a transmission and a pump drive member.The transmission may comprise a first motion transfer member (e.g. afirst gear and a first one-way clutch gear) mechanically interfaced witha portion of the pump drive member (e.g. an output shaft). In operation,turning the bi-direction drive member (e.g., bi-directional motor) in afirst direction (e.g., clockwise or counterclockwise) creates a firstoutput, which moves the first motion transfer member (e.g. first gear)and produces an output via (e.g., drives) the pump drive member (e.g.,output shaft). However, turning the bi-direction drive member (e.g.,bi-directional motor) in a second direction (e.g., counterclockwise orclockwise, whichever is the opposite of the first direction) produces asecond drive output, and at least a portion of the first motion transfermember slips such that no output is produced. In other words, the firstmotion transfer member does not drive the pump drive member in responseto the second dive output.

Also provided in the transmission may be a second motion transfer member(e.g. a second gear, a second one-way clutch and at least one additionaltransmission gear) mechanically interfaced with a portion of pump drivemember (e.g. the output shaft). In operation, turning the bi-directiondrive member (e.g., a bi-directional motor) in a first directionproduces no output via the second motion transfer member. In otherwords, at least a portion of a second motion transfer member slips inresponse to the first drive output. That is, the second motion transfermember does not drive the pump drive member in response to the firstdrive output. However, turning the bi-direction drive member (e.g., amotor) in a second direction imparts motion to (e.g., drives) the secondmotion transfer member (e.g. second gear, second one-way clutch and atleast one additional transmission gear) to produce a second output.

The medical fluid delivery system may further include a pump drivemember for providing a mechanical output in one direction. In oneapproach, the pump drive member is configured and arranged with thetransmission such that it is only capable of providing a mechanicaloutput in one direction. The pump drive member may be mechanicallyinterfaced with a pump, the pump being adapted to pump medical fluids.The medical fluid delivery system may further include a third motiontransfer member mechanically interfaced with the pump drive member andthe at least one additional gear, where the third motion transfer memberslips in response to the first drive output. In one approach, the pumpdrive member, moves in one direction at a first speed in response to thefirst drive output, and moves in the same one direction at a secondspeed in response to the second drive output. In one particular aspect,the first speed and second speed are different. In this regard, thefirst and second outputs may be utilized to drive the pump drive memberin one direction and over a wide-range of fluid delivery rates (e.g.,from 0.1 ml per hour to 1000 ml per hour).

The present invention also includes a method of providing a medicalfluid delivery system, which may include a pumping system operable overa range of motor speeds and torques, for delivering at least one medicalfluid over a wide-range of flow rates. In a particular embodiment thismethod includes providing a bi-direction drive member (e.g., abi-directional motor having a motor shaft and a motor gear attached tothe motor shaft), a first motion transfer member (e.g. a first gear anda first one-way clutch), where the first motion transfer member ismechanically interfaced with the bi-direction drive member and with aportion of a pump drive member (e.g. an output shaft). In operation, themethod includes operating the bi-direction drive member in a firstdirection, which moves the first motion transfer member to produce afirst output via the output shaft. However, operating the bi-directionaldrive member (e.g. bi-directional motor) in a second direction causesthe first motion transfer member to slip so no output is produced. Themethod further includes providing a second motion transfer member (e.g.,a second gear, a second one-way clutch and at least one additionaltransmission gear) mechanically interfaced with the bi-direction drivemember and a portion of a pump drive member (e.g. an output shaft). Inoperation, turning the bi-directional drive member (e.g. bi-directionalmotor) in the first direction produces no output from the second motiontransfer member, but turning the bi-directional drive member (e.g.bi-directional motor) in the second direction moves the second motiontransfer member to produce a second output. In one aspect, the first andsecond outputs are utilized to drive the pump drive member in onedirection to drive the pump to achieve a wide-range of fluid deliveryrates (e.g., from 0.1 ml per hour to 1000 ml per hour). The pump drivemember may be mechanically interfaced with a pump, the pump beingadapted to pump medical fluids.

In general terms, the medical fluid delivery system of the presentinvention may include a housing, a pumping system, (which may include adrive motor, a pump [e.g., a rotary peristaltic pump head] and atransmission), medical fluid lines through which a medical fluid may beflowed (e.g. pumped), a pump speed determination system, a processor forcontrolling the pump and a power source. Additional features of amedical fluid delivery system of the present invention may include adisposable medical fluid line set, which may include valves that may beopened, partially closed and closed to allow, impede (e.g., at leastpartially non-occlude), substantially occlude or completely occlude flowof a medical fluid. The medical fluid delivery system may also include avalve operating system adapted to interface with the valves of thedisposable medical fluid line set. The valve operating system mayinclude valve actuators adapted to interface with the valves to open andclose the valves. The valve operating system may also include a valvestatus determination system operable to interact with the valveoperating system for the selective actuation of one or more valveactuators.

The present invention also includes a method of pumping medical fluids.In a particular embodiment, the method includes providing a medicalfluid pumping means having a pumping system described herein andoperating such a system to pump a medical fluid.

In another particular embodiment, energy required to operate the medicalfluid delivery system of the present invention may be provided byvarious means, including, but not limited to, electricity, steam,hydropower, wind power, solar power, human or animal power and any othermeans known to produce energy.

The pump of the pumping system may include a pump head, which mayconsist of a rotary peristaltic pump mechanism, as is widely known inthe field. Briefly, in one aspect, the pump head comprises pinch members(e.g. spring-loaded pinch rollers) equally spaced around the pump headthat rotate about roller shafts on a sleeve bearing and pinch a medicalfluid line (e.g. flexible tubing) against an anvil surface. The pinchmembers may be designed to substantially occlude the medical fluid lineagainst the anvil, and, therefore, the pinch members may have theability to account for system tolerances of different medical fluid linesets. The pinch members may be biased away from the center of headrotation by a pinch-spring (e.g. coil torsion spring), which alsoretains the pinch roller on its shaft. The pinch members may be allowedto slide an amount slightly more than system tolerances toward and awayfrom the medical fluid line. The motive force may be the pinch-spring(e.g. a novel coil spring), which may engage the roller shafts on eitherside of the roller in a partial hole provided in the shafts. Thepinch-spring, therefore, maintains the placement of the rollers andprovides motive force.

The pump head rotates and pinches the medical fluid line against ananvil. In a particular embodiment, the anvil is movable to allow initialplacement of a medical fluid line in the channel provided. In aparticular embodiment, the anvil is also mechanically coupled to themotion of an angular element (e.g., a cover) of the medical fluiddelivery system. Briefly, to access the channels to put a medical fluidline into the pump, an angular element (e.g. cover) is provided thatrotates up to approximately 100 degrees about two hinge points. When thecover is opened, the anvil is drawn away from the pinch rollers to allowplacement of the medical fluid line. When the cover is closed, the anvilis moved towards the pinch rollers and the medical fluid line is pinchedtherebetween.

In one embodiment of the present invention, rotation of the pinchmembers in a first direction moves medical fluid from one or moremedical fluid delivery lines to a medical fluid output line (e.g., fordelivery to a patient). In an alternate embodiment, rotation of thepinch members in a second direction moves medical fluid from the medicalfluid output line to one or more medical fluid delivery lines. Use ofthe invention in the alternate embodiment would allow for distributionof a medical fluid into multiple receptacles, (e.g., as in apharmaceutical environment).

The coupling of the motion of the angular element of the medical fluiddelivery system (e.g., a cover) to the motion of the anvil may beaccomplished as described below. The angular element (e.g., cover) maybe pivotally connected to a housing by one or more hinges, as describedabove. The angular element (e.g., cover) may contain a partial internalgear ring adjacent to a hinge point, which may be arranged tomechanically connect to a gear on the anvil shaft. The gear of the anvilshaft may be chosen to have a pitch diameter smaller than the ring gearof the angular element (e.g., cover). The ratio of the ring gear to theanvil shaft gear may be chosen such that movement of the internal gearring moves the anvil an amount necessary to enable placement of themedical fluid line within the pump (e.g. 200 degrees of anvil shaftrotation for approximately 100 degrees of angular element (e.g., cover)rotation). The anvil shaft may be constrained to rotate by a sleevebearing and the anvil may be mechanically engaged to an offset portionof the anvil shaft by an engaging sleeve bearing. This engaging sleevebearing may be arranged to contact the anvil such that the rotary motionof the anvil shaft produces a linear motion of the anvil. The anvilshaft may also be arranged to rotate approximately 20 degrees pastmaximum displacement to provide a method of self-holding the anvil andcover in the open position.

In a particular embodiment, a cantilever force beam may be mechanicallyattached to the anvil such that as the anvil slides towards the pumphead, the end of the force beam contacts a medical fluid line at a pointdownstream from the pump head. This contact compresses the medical fluidline at the point of contact. Pressure inside the medical fluid linecauses the cantilever force beam to register more or less force in asubstantially linear fashion. The pressure information may be collectedcontinuously as the pump runs and sent to a computer processor, whichcan use the pressure information to determine whether the pumping systemis operating correctly. For example, the processor can determine whethera medical fluid source is empty or whether a medical fluid line isblocked by comparing current pressures to a known pressure profile.

In another aspect, a pressure relating to fluid flow through the medicalfluid line may be measured using a force sensor (e.g., a piezoelectricsensor) located downstream of the pump and in physical communicationwith the medical fluid output line. As is known in the art, the forcesensor may be communicatively coupled to a processor to collect pressureinformation about the medical fluid output line.

The motion of the rotary peristaltic pump head may be driven by abi-directional drive member (e.g. bi-directional motor) coupled with atransmission (e.g. a system of gears and clutches). In a particularembodiment, the drive motor may be a miniature DC iron-less core motor,with or without an integral gear train, and a motor gear frictionallyattached to the output shaft of the motor. In one approach, thebi-directional motor may be operated over a wide range of speeds (e.g.,by changing the supplied current and/or voltage to electricbi-directional drive motor) and intermittent times. Such speed variationand/or intermittent operation times, thus, enables the rotaryperistaltic pump head interfaced with such bi-directional drive motor todeliver medical fluids over a wide range of flow rates, in correspondingrelation to the first and second outputs over various speeds. Atransmission may be mechanically interfaced with the bi-directionaldrive motor and the pump head to help enable the pumping action, asdescribed in further detail below.

One of skill in the art would readily understand that fewer or greatergear combinations and/or gear ratios, as described herein, may beemployed to achieve the speed and torque required for the variousmedical fluid delivery rate ranges for any given application of thepump. In a particular embodiment, gear combinations may be formed of amolded material such as DELRIN or similar material, which provides itsown bearing surface on a shaft. However, one of skill in the art willappreciate that different materials could be employed to achieve thesame result.

Various methods known to those of skill in the art may be used tomeasure and control the motion of the pump head. In a particularembodiment, the medical fluid delivery system comprises a pump speeddetermination system, where the pump speed determination system includesan encoder (e.g., optical, reflective and/or magnetic). As will beappreciated, encoders are well known in the art and may be utilized inaccordance with well-known principles to determine the speed, motion,and/or position of the pump head. For example, the encoder may beutilized in relation to the motion of a pump drive member (e.g., anoutput shaft and/or pump drive shaft) to determine such speed, motionand/or position of the pump head. In a particular embodiment, theencoder may be an optical encoder, such as those supplied by US DigitalCommunications Inc (Chevy Chase, Maryland, U.S.A.), including the E4miniature optical encoder.

In a particular approach, the pump speed determination system mayutilize a magnets to determine the pump speed and/or motion. In thisregard, a portion of the pump drive member (e.g. an output shaft) mayhave four magnets equally positioned around its surface. A flex circuit,or other means of connecting electrical switches to a device controllermay be provided. For example, a flex circuit containing two reedswitches approximately 45 degrees rotationally apart may be placed on ahousing or other suitable location adjacent to the magnets to provide asignal for approximately 22½ degrees of the pump head. As the fourmagnets rotate over the reed switches, a signal is generated that can besent to a processor. Using this signal, the speed and direction ofrotation may be determined based upon the sequence of switch closure,which may allow the processor to insure the system is operating asrequested.

Valves and a valve operating system are also provided, as describedbelow. Initially, it is noted that many previously described systemsprovide valve mechanisms which are formed as part of the infusion pump.However, such arrangements are disadvantageous since once the medicalfluid delivery line is removed from the pump, accidental fluid movementto the patient can occur. Therefore, it is advantageous to provide avalve arrangement which cooperates with the mode of operation of theinfusion pump, but which can also be manually opened and closed apartfrom the operation of the infusion pump. In a particular embodiment,such a valve arrangement is designed to automatically close when a valveis removed from the medical fluid delivery system. A particularembodiment of the present invention may include a first pinch valve,which may be designed to be biased to a normally-closed position ornormally-open position.

Briefly, a pinch valve operates in a manner similar to a sprungclothespin in that it comprises two elongated members that are coupledby and/or biased by a spring or other biasing force located a distancefrom a pivot point, where the elongated members are forced together atone end and apart at the other. The valve is further adapted such that amedical fluid delivery line of a disposable medical fluid line set, asdescribed below, can be received by (e.g. run between) the elongatedmembers, and, thus, be pinched by the ends which may be normallytogether. Thus, when the valve is in a first position (e.g.normally-closed), fluid may not flow through the line. When force isapplied to compress the normally apart ends towards each other, thenormally together ends will be forced apart, (e.g., releasing thepinched medical fluid delivery line when employing a normally-closedvalve). Thus, when the valve is in a second position (e.g. open),medical fluid may flow through the medical fluid delivery line.

In a particular embodiment, the elongated members of the valve may haveeither a rib (e.g., a ridge) or a valley on the surfaces that maycontact the medical fluid line. In one embodiment, the elongated memberscomprise ribs which engage each other when the valve is in a closedposition, thereby substantially occluding fluid flow through a medicalfluid line interfaced therewith.

In another approach, a rib and valley may contact the medical fluid suchthat the line is formed (e.g. moved) into a serpentine path when thevalve is in a closed position. In a particular embodiment, a firstelongated member may have at least one rib about substantiallyperpendicular to the flow path of a medical fluid line. At least onevalley on the member surface of a second elongated member may interfacewith the at least one rib when the rib and valley are moved (e.g.biased) together. When the valve is in the closed position, the firstelongated member comprising the at least one rib and the secondelongated member comprising the at least one valley may compress (e.g.,pinch) the medical fluid line. As noted above, in one approach thepinching results in the forming of the medical fluid line into aserpentine path, thus forming at least three contact points, and atleast a portion of the inside walls of the line will be forced to meet.Thus, when the at least one rib and at least one valley pinch themedical fluid line, the at least three closure points effectively closethe medical fluid line. In one embodiment, when the valve is in the openposition (e.g., a non-pinching position), the at least one rib and atleast one valley of the elongated members may be spaced a sufficientdistance from each other to allow fluid flow through the medical fluiddelivery line.

In a particular embodiment, a plurality of guide members integral to theelongated members may be provided for insuring the medical fluid line isretained in the proper place, and that the line may be orientedcorrectly to be formed into a serpentine path. The elongated members,guides, rib(s), valley(s) and/or biasing means may be formed of anymaterial that will provide the required strength and flexibility, suchas plastic.

A system and method for opening and closing the pinch valves is alsoprovided. In one embodiment, the elongated members of a valve may beinterfaced with a valve actuator via first and second interfaceadaptations, respectively. In this embodiment the proximal ends of theelongated members of the valve may be, for instance, normally biasedaway from each other, such that the action of the valve actuator forcesthe proximal ends towards each other to open or close the valve. In oneaspect, the valve actuator may be held in place by a sleeve bearing,where the valve actuator is axially retained by an actuator returnmember (e.g. a torsion spring), which may be connected through thecenter of a valve actuator shaft. The actuator return member (e.g.torsion spring) may provide a motive force (e.g. a rotational motiveforce) to the valve actuator, and axially retain the valve actuator. Ina particular embodiment, the actuator return member (e.g. a torsionspring) axially retains the valve actuator by the inside edge of thespring wire passing through a central hole in the valve actuator shaft.The geometry of the wire form and the preload of the torsion spring mayprevent the valve actuator from disengaging from the sleeve bearing.

In one aspect, an actuator gear may engage the valve actuator by use ofa suitably sized rotational actuator clutch. This actuator clutch may befrictionally fit to the inside diameter of the actuator gear such thatthe actuator clutch is arranged to engage the valve actuator shaft whenthe actuator gear is being turned in a direction required to engage thevalve. When the actuator gear is turned in the opposite direction, theclutch slips causing no motion to the valve actuator or valve.

In a particular embodiment, a method for valve actuation is accomplishedas described below. The valve actuator is provided with secondadaptations (e.g. openings), which are adapted to receive firstadaptations (e.g. protrusions) of a pinch valve. As used herein,adaptations is used to broadly define openings and protrusions, forexample, slots and pins, respectively, which complement and receive eachother, and is not intended to limit these components to any particularshape or size. In one approach, the openings (e.g. slots) are arrangedto have a decreasing radius rotationally around one of the valveactuator or valve, so that as the valve actuator is rotated, thedecreasing radius of the valve actuator engages the mating firstinterface adaptations (e.g. pins) and forces the elongated members ofthe valve, which may be normally biased away from each other, toapproach each other, thereby opening or closing the valve. For example,the interface adaptations of the valve or valve actuator may be slots,where the slots have a wide proximal end, a narrow distal end, and anarcuate path between the wide proximal end and the narrow distal end,where at least a portion of the path tapers from the wide proximal endto the narrow distal end.

In one embodiment, the valve comprises at least one pin and the valveactuator comprises at least one slot adapt to receive the at least onepin. In another embodiment, the valve comprises at least one slot andthe valve actuator comprises at least one pin.

The valve operating system may also comprise valve interface members(e.g. actuator gears, actuator clutches, and valve actuators) andactivation members (e.g. mutilated gears). Each actuator gear may be inintermittent geared contact with a mutilated gear, which may pivot abouta shaft on a sleeve bearing. In one approach, each mutilated gear mayhave two or more vertical sections of teeth. A system utilizing twosections, referred to herein as “upper” and “lower” sections, isdescribed to exemplify the invention only. In a particular example, theedge of the lower section has teeth around the full perimeter (e.g.circumference), whereas the edge of the upper section has teeth on lessthan the full perimeter of the gear. The amount of the edge of the uppersection having teeth is determined by the number of valves to becontrolled. For example a two-valve system may have gear teeth onapproximately one-half of the perimeter of the upper section, while in asystem having four valves the upper section of the mutilated gear wouldhave gear teeth on approximately one-quarter of the perimeter, (e.g.equal to about 90 degrees of rotation). For example, in a four-valvesystem, the actuator gear may be arranged to make and break contact withthe mutilated upper section of the mutilated gear, thus providing asystem where each actuator gear is in geared contact for approximately90 degrees of rotation of its corresponding mutilated gear. In aparticular embodiment, the mutilated gears may be arranged in an arcsuch that the lower section of each mutilated gear is in geared contactwith a central drive gear. This arrangement provides a central locationwhere a central drive gear can drive a plurality of mutilated gearssimultaneously, and where less than all actuator gears and correspondingvalve actuators are imparted motion from the central drive gear via themutilated gears at any given time.

Alternately, multiple valves may be opened at the same time. Forexample, an activation member (e.g. a mutilated gear) with 180 degreesof coverage in the upper section may be used in a four-valve system. The180 degrees of coverage may be contiguous, thus opening two neighboringvalves or may consist of two 90 degree sections opposing each other suchthat every other valve may be opened simultaneously. Likewise, anactivation member (e.g., mutilated gear) with full coverage on the uppersection could be used in a four-valve system to open all four valvessimultaneously. One of skill in the art will understand that variousactivation member arrangements could be employed in the valve operatingsystem to open and close different valves independently, simultaneouslyand in numerous combinations.

In another aspect, the medical fluid delivery system comprises a valvestatus determination system, which may calculate the speed, motionand/or position of the various members of the valve controller. In aparticular aspect, the valve status determination system includes anencoder (e.g., optical, reflective and/or magnetic). As described above,such encoders are well known in the art and may be utilized inaccordance with well-known principles to determine the speed, motionand/or position of the various component of the valve controller Forexample, the encoder may be utilized in relation to the central drivegear. In a particular embodiment, the encoder may be an optical encoder,such as those supplied by US Digital Communications Inc (Chevy Chase,Md., U.S.A.), including the E4 miniature optical encoder.

In an another embodiment, magnets may be employed where a central drivegear may contain four magnets that are arranged to rotate above two reedswitches approximately 45 degrees rotationally apart. As the fourmagnets rotate over the two reed switches, a signal may be generatedwhich may be sent to a processor. Using this signal, both speed ofrotation and direction of rotation can be determined based upon thesequence of switch closure, allowing the processor to insure the valveoperating system is operating as requested.

In one approach, the valve operating system comprises a central drivemember, which may comprise the central drive gear, a drive motor and amotor gear. The central drive gear may be in geared contact with thedrive motor, either directly or through one or more transfer gears (e.g.a motor gear). The drive motor may be a standard brushed DC motor withan integral gear reduction that can be driven either unidirectionally orbi-directionally. This motor may be sized to deliver appropriate speedand torque to the valve actuator through activation members to motivatethe opening of valves. In a particular embodiment, as the motor gearmoves in a first direction (e.g. clockwise), the central drive gearturns all four activation members (e.g. mutilated gears) simultaneously,whereby the actuator gears are rotating in a direction of slip withrespect to their actuator clutches. Thus, none of the valve actuatorswill be moved when the motor gear moves in a first direction.

As the motor gear moves in a second direction (e.g. counterclockwise),at least a single actuator gear may be engaged by (e.g. interfaced with)an activation member at any one time due to the rotational offsetarrangement of the activation members (e.g. mutilated gears). Anactuator gear in geared contact, therefore, will be required to rotatein a direction that causes each clutch of each actuator gear to engageand thereby rotate each valve actuator. As the motor gear moves (e.g.rotates) in the second direction, the motor provides motive force torotate the valve actuator in order to open the valve. The actuatorreturn member (e.g. a torsion spring) of the valve actuator may providea motive force to automatically rotate the valve actuator to an initialposition (e.g., starting position) when the motive force of the motor isremoved, thereby closing the valve. Thus, the motive force or the valvecontroller (e.g. a motor) can be rapidly placed in random contact witheach valve actuator (e.g. via the actuator gear) for opening acorresponding valve (e.g. by moving clockwise or in the direction ofnon-engagement for the actuator clutches), thus providing a means foropening a single valve at a time without disturbing the fluid valvesthat are not meant to be opened.

In one embodiment, the elongated members of the valve and/or the valveactuator have walls comprising a slight taper. In the initial restposition the valves may be closed and fit loosely in the secondinterface adaptations (e.g., the valve actuator slots/recesses). With amedical fluid delivery system cover in place, the valves will be held inthe recesses provided and will be forced to open by the action of thevalve actuators. However, if the cover is opened while the valveactuator is acting on a valve, the restraining force of the cover isremoved and the taper of valve and/or valve actuator walls lifts thevalve out of the recess, where a biasing means (e.g. a spring) may causethe valve to return to a closed and safe (e.g. no fluid flow) position.Thus, the cover of the present invention may have dual functionality inthat may act as a restraining force to maintain the valves within themedical fluid delivery system, and, as described earlier, it may act asan angular element to assist in the placement of a medical fluid linewithin the pump.

In one approach, the valve operating system may comprise a valve statusdetermination system, which may comprise sensors to verify valve motion.In a particular embodiment, electrical switches are placed such that aportion of the switch protrudes into a valve housing area. In theabsence of a valve, the switch is closed. In the presence of a valve,the switch is opened. As the valve is opened by a valve actuator, theswitch again closes and provides a means for a device control unit todetermine the number of valves being operated, and the position of eachvalve at any given time during operation.

In another embodiment, a disposable medical fluid line set is provided,which may include the valves described herein. When multiple fluiddelivery lines are provided, each medical fluid delivery line may be influid communication with a common manifold, which in turn may be influid communication with a medical fluid output line, which mayinterface with a pump head. The fluid lines and manifold describedherein may be molded or formed as a single, contiguous piece, or may beseparate pieces in fluid connection with each other. In a particularembodiment, the medical fluid lines may be made of medical gradesilicone tubing, which may either be extruded and cut to length orinjection molded to final shape. Also, the manifold may be injectionmolded of the same silicon as part of a line molding process orinjection molded as a separate piece of medical grade plastic.

In another aspect, an inventive medical fluid delivery system mayutilize a disposable medical fluid line set in the delivery of aplurality medical fluids. In this regard, an inventive medical fluiddelivery system is provided for the delivery of one or more medicalfluids. The medical fluid delivery system may include a medical fluidline set, which may include a first medical fluid delivery line fordelivering a first medical fluid therethrough, and a first valve adaptedto interconnect with the first medical fluid line. In one approach, thevalve is one of fixedly interconnected and slidably interconnected tothe first medical fluid delivery line. When the valve is slidablyinterconnected to a medical fluid line, the valve may be move about thefluid line and may be retained at either end of the medical fluid lineby a spike or other stopping member.

In another embodiment, the first valve includes a biasing means forbiasing the first valve in one of a normally-closed position andnormally-open position. In one embodiment, the first valve has a firstinterface adaptation (e.g., at least one protrusion).

The medical fluid delivery system of may further include a first valveactuator having a second interface adaptation (e.g., at least oneopening). The second interface adaptation may be configured to interfaceand co-move with the first interface adaptation of the first valve. Inone particular approach, the first interface adaptation and the secondinterface adaptation are sized to matably receive each other. In oneparticular aspect, the second interface adaptation is a slot thatincludes a wide proximal end for matably receiving the first interfaceadaptation, a narrow distal end, and an arcuate path between the wideproximal end and the narrow distal end which tapers down to the narrowend. In this particular aspect, the first interface adaptation is sizedto matably engaged the slot at a point along the arcuate path.

In one approach, the first valve actuator is positionable to a first andsecond position, where in the first position a portion of the firstmedical fluid delivery line is pinched by the valve, therebyaccomplishing a first degree of occluding of fluid flow through thefirst medical delivery line, wherein fluid flow through the medicaldelivery lined is at least substantially occluded, if not fullyoccluded. When the first valve actuator is in the second position, asecond-degree of occluding of the medical fluid delivery line isaccomplished, where fluid flow through the medical delivery line is atleast partially non-occluded, and in some instances, completelynon-occluded (e.g., open).

In one particular aspect, the first interface adaptation and secondinterface adaptation of the valve and valve actuator, respectively, arematably engaged in the second position to open the first valve. In yetanother approach, the medical fluid delivery system includes an actuatorreturn member operatively interfaced with the valve actuator and adaptedto automatic return the first valve actuator from the second position tothe first position. The actuator return member may be in the form of abiasing means, such as a torsion spring.

In another embodiment, the medical fluid delivery system furtherincludes a second medical fluid delivery line, a second valve adapted tointerconnect with the second medical fluid delivery line, and a secondvalve actuator for interfacing with the second valve. In one aspect, thesecond valve comprises at least one of the first interface adaptationand second interface adaptation, and the second valve actuator comprisesat least one of the first interface adaptation and second interfaceadaptation. In one particular approach, the first and second valve eachcomprise the first interface adaptation and the first and second valveactuator each comprise the second interface adaptation. In oneembodiment, the second valve is fixedly interconnected to the secondmedical fluid delivery line.

In another aspect, the medical fluid delivery system may include a valvecontroller adapted to mechanically impart motion to the first valveactuator and second valve actuator. In this regard, a first motionoutput of the valve controller will at least partially actuate the firstvalve actuator, and a second motion output of the valve controller willlease partially actuate the second valve actuator. In one particularapproach, the first motion output and second motion output are at leastpartially non-overlapping. In one aspect, the first motion output andsecond motion output are entirely non-overlapping.

In another approach, the medical fluid delivery system includes abi-directional motor, a transmission adapted to mechanically interfacewith a bi-directional motor, and a pump drive member for providing amechanical output in one direction. In this regard, the pump drivemember is adapted to mechanically interface with the transmission andthe pump, where operation of the bi-directional motor in a firstdirection produces a first output that drives the pump drive member inone direction. Further in this regard, the pump drive member is adaptedto mechanically interface with the transmission of the pump, whereoperation the bidirectional motor in a second direction produces asecond output that drives a pump drive member in the same one direction.

The present invention also includes an inventive method for use in thedelivery of one or more medical fluids. In this regard, the inventivemethod may include the steps of providing a medical fluid line set,interconnecting a pump with the medical fluid output line of the medicalfluid line set, interfacing a first interface adaptation of a firstvalve of the medical fluid line set with a second interface adaptationof a first valve actuator, actuating the first valve actuator to movethe first valve from a first position to a second position, andoperating, during the actuating step, the pump to deliver a firstmedical fluid. In this regard, the medical fluid line set may includethe first valve, the medical fluid output line, and a first medicalfluid delivery line fluidly interconnected to a first medical fluidsource. The first valve may be interconnected with the first medicalfluid delivery line, such as fixedly interconnected.

In one aspect, the actuating comprises rotational movement of the firstvalve actuator, and the rotational movement of the first valve actuatorcomprises no more than 180 degrees of rotation. In another aspect, theoperating the pump step comprises the steps of first moving abi-directional drive member in the first direction to move the pump inone direction at a first speed, and second moving the bi-directionaldrive member in a second direction to move the pump in the same onedirection at a second speed.

The method may further include the step of automatic returning the valveactuator to the first position after the actuating step. In oneapproach, during the actuating step, the first interface adaptation andsecond interface adaptation are matably engaged. In this regard, one ofthe first interface adaptation and second interface adaptation maycomprise an opening, and the other of the first interface adaptation andsecond interface adaptation may include a protrusion. Further in thisregard, the interfacing step may comprise the step of inserting theprotrusion into the slot.

In another approach, the method may include the steps of interfacing afirst interface adaptation of a second valve with a second interfaceadaptation of a second valve actuator, de-actuating the first valveactuator to return the first valve actuator to the first position, andsecond actuating the second valve actuator to move the second valve froma first position to a second position. In this regard, when the secondvalve actuator is in the first position, the second valve willsubstantially or completely occlude fluid flow through a second medicalfluid delivery line. When the second valve actuator is in the secondposition, the second valve permits fluid flow through the second fluiddelivery line. Further in this regard, the medical fluid line setincludes the second medical fluid delivery line, which is fluidlyinterconnected to a second medical fluid source and the medical outputline, and the second valve which is interconnected with the secondmedical fluid line. In this approach, the method may further include thestep of operating the pump to deliver the second medical fluid duringthe second actuating step. In another aspect of this approach, the firstactuating step of the method may further include the steps of firstcreating a first motion output of valve controller, and second creatinga second motion output of the valve controller, where the first motionoutput and second motion output are at least partially non-overlapping.In this regard, the valve controller is mechanically interfaced with thefirst valve actuator and the second valve actuator.

In another embodiment, the method may include the step of moving acomponent of the pump in linear response to an angular output of anangular element to enable placement of a portion of a medical fluid linein at least a portion of the pump. In this regard, the component of thepump may be an anvil and the angular element may be a cover. The angularoutput may also comprise rotational movement of the angular element froma first position to a second position. As used herein, “angular element”means any element associated with the medical fluid delivery system thatmay move from a first angle to a second angle, such as by rotationalmovement. In particular, the angular element may include covers, shafts,motion transfer members (e.g. gears) and the like.

The present invention also includes an inventive valve operating systemfor use in delivering a plurality of medical fluids. The valve operatingsystem may include first and second valve interface members, which mayinclude first and second valve actuators adapted to operativelyinterface with first and second medical fluid delivery valves,respectively. The valve operating system may further include a valvecontroller mechanically interfaced with the first and second valveinterface members. In this regard, the valve controller may produce afirst output that at least partially actuates the first valve actuator,and a second motion output that at least partially actuates the secondvalve actuator. In one aspect, the first motion output and second motionoutput are at least partially non-overlapping. In one particular aspect,the first motion output and second motion output are non-overlapping. Inone embodiment, the first motion output of the valve controllercorresponds to movement of the valve controller from a first controllerposition to a second controller position, and the second motion outputof the valve controller corresponds to movement of the valve controllerfrom the second controller position to a third controller position.

In one embodiment, the valve controller includes first and secondactivation members adapted to operatively interface with the first andsecond valve interface members, respectively. In this embodiment, in thefirst controller position, the first activation member of the valvecontroller is at least partially interfaced with the first valveinterface member, and the second activation member is at most partiallyinterfaced with the second valve interface member. In the secondcontroller position, the first activation member is partially interfacedwith the first valve interface member, and the second activation memberis partially interfaced with the second valve interface member. In thethird controller position, the first activation member is at mostpartially interfaced with the first valve interface member, and thesecond activation member is at least partially interfaced with thesecond valve interface member. In one approach, in the first controllerposition the second activation member is not interfaced with the secondvalve interface member.

In one embodiment, the first and second motion outputs of the valvecontroller comprise circular rotation of at least a portion of the valvecontroller. In this regard, the first motion output may be a firstarcuate rotation of a first activation member, and the second motionoutput may be a second arcuate rotation of a second activation number.In one approach, the first arcuate rotation corresponds to rotation ofthe first activation member by no more than 180 degrees. In anotherapproach, the second arcuate rotation corresponds to rotation of thesecond activation member by no more than 180°. Further this regard, thefirst and second arcuate rotations may occur at least coincidentally(e.g., in overlapping temporal relation or even contemporaneously).

In another approach, the activation members (e.g., first, second, etc.)included an upper section adapted to mechanically interface with thefirst of interface member, and a lower section mechanically interfacedwith a central motion transfer member. The upper section includes anactive interface portion extending about a segment of the perimeter ofthe lower section of each activation member. The lower section includesa motion transfer mechanism (e.g., geared teeth) about the entireperimeter of the lower section of each activation member. In oneapproach, the active interface portion is contiguous. In anotherapproach, the active interface portion is noncontiguous. In oneparticular embodiment, the active interface member comprises gear teethfor mechanically interfacing with its respective valve interface member.As used in this paragraph, the terms “upper” and “lower” are used forillustration purposes only, and are not meant to be limiting in anyfashion.

The present invention also includes an inventive method for delivering aplurality of medical fluids. In this regard, the method comprises thesteps of fluidly interconnecting at least first and second medical fluiddelivery lines with one pump, first operating the one pump to deliver afirst medical liquid through the first medical fluid delivery line, andsecond operating the one pump to deliver a second medical liquid throughthe second medical fluid delivery line, where the first operating andsecond operating steps occur during the fluidly interconnecting beingstep.

In one approach, the fluidly interconnecting step further comprises thesteps of interfacing a first valve interconnected with the first medicalfluid delivery line with a first valve actuator, and interfacing asecond valve interconnected with the second medical fluid delivery linewith a second valve actuator. In this regard, the method may furthercomprise the step of first positioning a valve controller from a firstcontroller position to a second controller position to actuate the firstvalve actuator. In one approach, the second valve actuator remains in anon-actuated position during the first positioning step. Further in thisregard, the method may further comprise the step of second positioningthe valve controller from the second controller position to a thirdcontroller position to actuate the second valve actuator. As will beappreciated with this approach, the method is able to achievesynchronous or non-synchronous coincidental movement of one or morevalve actuators utilizing a single valve controller, as is described infurther detail below. This approach is especially useful when employinga plurality of medical fluids for delivery, as it is often desirable toactuate certain valves in a particular order to achieve the desiredmedical fluid delivery.

In another embodiment, the method further comprises actuating the firstvalve actuator. In one approach, this actuating step may comprise thesteps of first moving a valve controller in a first direction anddriving the first valve actuator from a non-actuated position to anactuated position during the first moving step. Further in this regard,the actuating step may further comprise the step of second moving thevalve controller in a second direction to position the valve controllerfor the first moving step, where the second moving step occurs prior tothe first moving step. In one approach, the second valve actuatorremains in a non-actuated position during the second moving step. In yetanother approach, the second valve actuator remains in a non-actuatedposition during both the first moving and second moving steps. As willbe appreciated with this embodiment, the method is able to achievecontrolled opening of a selected valve without opening other valveswithin the medical fluid delivery system, as it described in furtherdetail below. This embodiment is especially useful when employing aplurality of medical fluids for delivery, as it is often desirable toactuate only one valve without actuating other valves to avoidunintentional or unwanted medical fluid delivery.

In another approach, the actuating step occurs prior to the secondoperating step. In another embodiment, the method further comprises thestep of second actuating the second valve actuator. In one approach, themethod further comprises automatically returning the first valveactuator to a non-actuated position after the first positioning step.

In another embodiment, the method may include the step of relating thefirst valve to the first valve actuator by matching a color designationof the first valve to a color designation of the first of actuator. Themethod may further comprise the step of moving, prior to the fluidlyinterconnecting step, a component of the pump in linear response to anangular output of an angular element to enable placement of a portion ofthe medical fluid output line in at least a portion of the pump. In thisregard, the component of the pump may be an anvil and the angularelement may be a cover. The angular output may also comprise rotationalmovement of the angular element from a first position to a secondposition.

The present invention also provides for an inventive method fordelivering a medical fluid at varying rates using a single pump. Themethod may include the steps of interconnecting a medical fluid linewith one pump, first operating a bi-directional drive member in a firstdirection to produce a first drive output, and second operating thebi-directional drive member in a second direction to produce a seconddrive output.

In one embodiment, bi-directional drive member is operable over anoperating range, which may corresponds to a range of first outputs andsecond outputs. In one embodiment, the range of first outputscorresponds to a first medical fluid delivery rate range, and the rangeof second outputs corresponds to a second medical fluid delivery raterange. In one particular aspect, the first and second medical fluiddelivery rate ranges are at least partially non-overlapping. In anotheraspect, the first and second medical fluid delivery rate ranges arenon-overlapping.

Further in this regard, each of the first and second medical fluiddelivery rate ranges may have maximum and minimum flow rates associatedtherewith. In one embodiment, the first medical fluid delivery raterange has a maximum flow rate 2000 ml per minute, more particularly 1000ml per minute, and a minimum flow rate of 1 ml per minute, moreparticularly 5 ml per minute, even more particularly 10 ml per minute.In one embodiment, the second medical fluid delivery rate range has amaximum flow rate of 100 ml per minute, more particularly 50 ml perminute, and a minimum flow rate of 0.1 ml per minute, more particularly1 ml per minute.

In one aspect of the method, the operating step comprises movement ofthe bi-directional drive member in one of a clockwise a counterclockwisedirection, and second operating step comprises movement of thebi-directional drive member in the opposite direction of the firstoperating step. In one embodiment, the first operating step includes thestep of first driving the pump drive member in a rotational direction inresponse to motion from a first motion transfer member. In this regard,the pump drive member is mechanically interfaced with the one pump and afirst motion transfer member, and the first motion transfer member ismechanically interfaced with bi-directional drive member. In aparticular embodiment, the second operating step comprises the step ofsecond driving the pump drive member in the same rotational direction inresponse to motion from a second motion transfer member. In this regard,the pump drive member is mechanically interfaced with the second motiontransfer member, and the second motion transfer member is mechanicallyinterfaced with the bi-directional drive member. In one aspect, thesecond motion transfer member does not drive the pump drive memberduring the first driving step. In another aspect, the first motiontransfer member does not drive the pump drive member during the seconddriving step.

The present invention also provides for an inventive medical fluiddelivery system including a pinch valve adapted for receiving andengaging a medical fluid line, where the pinch valve will substantiallyor completely occlude fluid flow through a medical fluid delivery linereceived therein when the pinch valve is in a first position.

The pinch valve generally includes a first and second elongated membersand a biasing means for forcing the first and second elongated membersin at least a first direction about a pivot point to said first positionto substantially or completely occlude fluid flow. The pinch valve mayalso include at least one rib, a second elongated member that includesat least one valley, and a biasing means for forcing at least one of thefirst and second elongated members in a first direction about a pivotpoint. At least one of the first and second elongated members may beadapted to receive the medical fluid delivery line. In this regard, in afirst position of the pinch valve, a portion of the medical fluiddelivery line is pinched between the first and second elongated members.In a particular approach, the portion of the medical fluid delivery lineis formed into a serpentine path about the at least one rib at least onevalley. The at least one rib and at least one valley are adapted forinterfacing with each other to form the portion of the medical fluidline into the serpentine path when the pinch valve is in the firstposition.

In one aspect, in the first position the portion of the medical fluiddelivery line is contacted in at least three points by the pinch valve.In a particular embodiment, in the first position, medical fluid issubstantially or completely occluded from flowing through the portion ofthe medical fluid delivery line. Further in this regard, in a secondposition of the pinch valve, medical fluid may flow through a portion ofmedical fluid delivery line.

In a particular embodiment, the pinch valve includes at least oneinterface adaptation for interfacing the pinch valve with a valveactuator. In this regard, the at least one interface adaptation may beone of a opening (e.g., a slot) or a protrusion (e.g., pin). In oneaspect, the opening may be size for may be receiving a protrusion. Inanother aspect, the protrusion may be size for may deplete protrudinginto an opening.

In another embodiment, the pinch valve may include a first colordesignation for relating the pinch valve to a valve actuator. In anotheraspect, the pinch valve may comprise a lock mechanism for locking thepinch valve into a second position a portion of a medical fluid deliveryline is at least partially non-occluded. In this regard, the lockmechanism may be operatively interconnected with at least one of thefirst and second elongated members to maintain the pinch valve in thesecond position. In a particular aspect, the lock mechanism is fixedlyor slidably interconnected to at least one of the first and secondelongated members. In another aspect, the lock mechanism is readilyremovable (e.g. a disposable) from the pinch valve.

The present invention also provides for an inventive method fordelivering a medical fluid. The method may include the steps of firstinterconnecting a plurality of valves to a corresponding plurality ofmedical fluid delivery lines, the plurality of valves and plurality ofmedical fluid delivery lines defining a medical fluid line set,interfacing the medical fluid line set with the pumping system, anddelivering medical fluid through at least one of the plurality ofmedical fluid delivery lines using the pump. The method provides for atleast the first interconnecting step to occur at a first location (e.g.,a manufacturing, cleaning, preparation and/or sterilization facility),and at least the delivery step to occur at a second location remote fromthe first location. The second location can be any location remote fromthe first location has a need to deliver a medical fluid, such as amedical care facility or pharmaceutical facility.

In one embodiment, the interconnecting step of the method comprisesfixedly attaching the plurality of valves to the corresponding pluralityof medical fluid delivery lines. In another embodiment, the methodfurther comprises the step of second interconnecting the plurality ofmedical fluid delivery lines with the manifold. In this regard, thesecond interconnecting may occur at the first location. Further in thisregard, the interfacing step method may include the steps of thirdinterconnecting the manifold with a medical fluid output line, andplacing the medical fluid output line at a portion of the pump. In oneapproach, the interfacing the step also occurs at the second location.

In another embodiment, the method may comprise the step of transferringthe medical fluid line set from the first location to another location .In a particular aspect, the another location is the second location. Ina further embodiment, the method may comprise the step of actuating atleast one of the plurality of valves to a non-pinching position prior tothe transferring step (e.g., such as at a manufacturing, cleaning,preparation and/or sterilization facility). Further in this regard, inthe non-pinching position the at least one of the plurality of valvesdoes not substantially pinch a corresponding one of the plurality ofmedical fluid delivery lines. In another embodiment, the method maycomprise maintaining the at least one of the plurality of valves in thenon-pinching position during the transferring step. In yet anotherembodiment, the method may comprise the step of de-actuating the atleast one of the plurality of valves to place the at least one of theplurality of valves in a pinching position. In this regard, thede-actuating step may occur after the transferring step, such as at thesecond location (e.g., a medical care facility and/or pharmaceuticalfacility). In another aspect, the method may comprise the step ofpackaging the medical fluid line set. Further in this regard, thepackaging step may occur after the actuating step (e.g., at amanufacturing, cleaning, preparation and/or sterilization facility). Inanother aspect, the method may comprise the step of sterilizing themedical fluid line set. In this regard, the sterilizing step may occurbefore the transferring step.

In another aspect, the method may comprise the step of relating theplurality of valves to the plurality of medical fluid delivery lines. Inthis regard, the relating step may comprise the step of matching a colordesignation of the plurality of valves to a color designation of theplurality of medical fluid delivery lines.

In another embodiment, the method may comprise the step of secondinterfacing the plurality of valves with a corresponding plurality ofvalve actuators. In this regard, each of the plurality of valves maycomprise a first interface adaptation, and each of the plurality ofvalve actuators may comprise a second interface adaptation forinterfacing with the first interface adaptation. The method may furthercomprise the step of relating the plurality of valves to the pluralityof valve actuators prior to the second interfacing step. In this regard,the relating step may comprise matching a color designation of acomponent of the medical fluid line set to a color designation of asecond component. Further in this regard, the component of the medicalfluid line set may be one of the plurality of valve actuators and theplurality of medical fluid delivery lines. In another aspect, the secondcomponent may comprise the plurality of valve actuators. In anotheraspect, the second component may comprise a housing element, such as arecess of the housing or a port of a housing.

In another embodiment, the method may include the steps of moving acomponent of the pump in linear response to an angular output of anangular element to enable placement of a portion of a medical fluid linein at least a portion of the pump. In this regard, the component of thepump may be an anvil and the angular element may be a cover. The angularoutput may also comprise rotational movement of the angular element froma first position to a second position.

As will be appreciated, the inventive medical fluid delivery system maydeliver a one or more plurality of medical fluids (e.g., to a patient orreceptacle) using a medical fluid delivery system comprising anyone ofthe following, either alone or in combination: a pinch valve; adisposable medical fluid line set; a pumping system, which may comprisea drive motor system, a transmission, a pump drive member and/or a pump;a valve operating system; a pump speed determination system; a valvestatus determination system; a pressure measurement system; a powersupply; a computer processor and control system; and/or a housingadapted to receive any of such items.

In one aspect, portions of the disposable medical fluid line set, (e.g.valves and/or a manifold) may be placed in corresponding recessesprovided in a housing. The valves may be placed in valve recesses and aportion of the disposable medical fluid line set may be placed tointerface with a rotary peristaltic pump head. Once in the properrecesses, particular elements of the disposable medical fluid line setmay be further held in place by closing a cover. One or more separatemeans may be provided to assist in maintaining the disposable medicalfluid line set in its proper position in the housing.

In another aspect, it may be desirable to hold the valves in the openposition (e.g., non-pinching position) during product storage to preventthe medical fluid lines from being permanently deformed or collapsed bythe pressure of the valve during storage or due to elevated temperature.In a particular embodiment, the disposable medical fluid line setpackaging is arranged of semi-rigid vacuum formed plastic withappropriate structures to hold the valve in the open position duringsterilization or storage.

In a particular embodiment, the medical fluid pumping system comprises apump speed determination system that may sense pump head motion of byoptical encoders and/or reed switches, described above. However controlof the amount of rotation relates to the motor armature. The pump headdiameter, the medical fluid line inside diameter, the transmissioncomponents (e.g. gears and their ratios), and the pump drive membercomponents (e.g. worm gear ratio), may be matched in a fashion that thespeed ratios of the transmission overlap and provide sufficient torquemultiplication for the motor at both speed ranges, yet not overrun themotor armature speed.

The medical fluid pumping system may be controlled by many types ofmicroprocessors commonly used for control applications. As commonlyunderstood, the processor may accept the command inputs of the keys,display the status on a display, monitor the sensors for faultconditions, monitor the voltages of batteries, and direct the valveoperating system and/or pumping system for correct operation.

One of skill in the art would readily understand that a medical fluiddelivery system of the present invention may also have additionalfeatures useful for medical applications. For example, the medical fluiddelivery system may comprise interface members so that the medical fluiddelivery system may be operated on either battery power or on standardelectrical outlets. The medical fluid delivery system may have variousclips or features for holding items commonly found in settings wheremedical treatments are administered, such as clips suitable forattaching standard syringes. The medical fluid delivery system may alsohave features for mounting or hanging the medical fluid delivery systemon a pole, which may be integral to the medical fluid delivery system,or removable in nature. An example of such a pole mount is one whichmagnetically attaches the medical fluid delivery system to the pole withsufficient force to allow an operator to actuate the keys, but willdisengage from the pole should the patient be moved away from themounting pole without first removing the medical fluid delivery systemfrom the pole.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is as a schematic view of one embodiment of the medical fluiddelivery system of the present invention.

FIG. 2 is a schematic view of one embodiment of the medical fluid lineset of the present invention.

FIG. 3 is a schematic view of one embodiment of the medical fluid lineset and valve operating system of the present invention.

FIG. 4 is a schematic view of one embodiment of the pumping system ofthe present invention.

FIG. 5 is a perspective view of one embodiment of a valve of the presentinvention.

FIG. 6 is a cross-sectional view of one embodiment of a valve of thepresent invention.

FIG. 7 a is a perspective view of one embodiment of a valve and a valveactuator of the present invention.

FIG. 7 b is a top view of one embodiment of a valve actuator of thepresent invention.

FIG. 8 is a perspective view of one embodiment of a valve operatingsystem of the present invention.

FIG. 9 a is a top view of one embodiment of an activation member of thepresent invention.

FIG. 9 b is a side view of one embodiment of an activation member of thepresent invention.

FIG. 9 c is a perspective view of one embodiment of a valve operatingsystem of the present invention.

FIG. 10 is a perspective view of one embodiment of a valve statusdetermination system of the present invention.

FIG. 11 a is a perspective view of one embodiment of a transmission ofthe present invention.

FIG. 11 b is a perspective view of one embodiment of a transmission ofthe present invention.

FIG. 12 is a perspective view of one embodiment of a pump speeddetermination system of the present invention.

FIG. 13 is an exploded view of one embodiment of a pump of the presentinvention.

FIG. 14 a is a perspective view of one embodiment of the medical fluiddelivery system of the present invention.

FIG. 14 b is a perspective view of one embodiment of the medical fluiddelivery system of the present invention.

FIG. 14 c is a perspective view of one embodiment of a cover and pumpanvil of the present invention.

FIG. 14 d is a top-view of one embodiment of a cover and pump anvil ofthe present invention.

FIG. 15 is a perspective view of one embodiment of the medical fluiddelivery system of the present invention.

FIG. 16 is an exploded view of one embodiment of the medical fluiddelivery system of the present invention.

FIG. 17 a is a chart relating fluid flow rate to motor armature speedand pump duty cycle in one embodiment of the present invention.

FIG. 17 b is a chart relating fluid flow delivery rate to the number oflines being utilized according to one embodiment of the presentinvention.

FIG. 18 a is a chart of a minimum first direction motor speed profileaccording to one embodiment of the present invention

FIG. 18 b is a chart of a minimum second direction motor speed profileaccording to one embodiment of the present invention

DETAILED DESCRIPTION OF THE INVENTION

Definitions

For the purposes of the present invention, the following terms shallhave the following meanings:

For the purposes of the present invention, “a” or “an” entity refers toone or more of that entity; for example, “a valve actuator” or “an pinchvalve” refers to one or more of the components or at least onecomponent. As such, the terms “a” or “an”, “one or more” and “at leastone” can be used interchangeably herein. It is also noted that the terms“comprising,” “including,” and “having” can be used interchangeably.Furthermore, a component “selected from the group consisting of” refersto one or more of the components in the list that follows, includingmixtures (i.e. combinations) of two or more of the components.

As used herein, a “pump” refers broadly to means for moving fluid. Apump may operate through changes in pressure and/or gravity. Pumpsinclude but are not limited to rotary peristaltic pumps, linearperistaltic pumps, centrifugal pumps, diaphragm pumps and piston pumps.

As used herein, a “fluid” refers to any matter having fluidicproperties, including but not limited to liquids, suspensions, gases andmixtures thereof.

As used herein, a “motion transfer member” is intended to broadly referto any structure commonly used to transfer or receive a motion. Motiontransfer members of the present invention may include, for example,gears, toothed or cogged structures, chains, pulleys, friction devices,magnetic couplings and combinations thereof.

The present application hereinafter describes the use of an inventivedrive motor system, valve operating system, fluid line set and pinchvalve in the context of a medical fluid delivery system. One of skill inthe art will readily understand that the drive motor system in referenceto a medical fluid delivery system could be readily utilized as themotive force in any number of devices, as described above.

Reference will now be made to the accompanying drawings, which at leastassist in illustrating the various pertinent features of the presentinvention. FIG. 1 illustrates a medical fluid delivery system accordingto the present invention. The medical fluid delivery system 102 maygenerally comprises a disposable medical fluid line set 110, a valveoperating system 140, and a medical fluid pumping system 170. Thedisposable medical fluid line set 110 is generally fluidly connected toone or more medical fluid sources 104 and may be fluidly connected to amanifold 114. A medical fluid output line 116 may be fluidly connectedto the manifold 114 at a proximal end and to a patient, via an IVcatheter, at a distal end. In one embodiment, the medical fluid outputline 116 is connected to a patient P via a coupler 118 for selectivelyconnecting first and second portions of the medical fluid output line116. As will be described in further detail below, the disposablemedical fluid line set 110 may interface with the valve operating system140 via valves 120. Generally, the valve operating system 140 operatesthe valves 120 of the disposable medical fluid line set 110 to enabledelivery of one or more medical fluids to a patient P via the pumpingsystem 170.

In one embodiment, the medical fluid delivery system 102 may include adisposable medical fluid line set 110, which is now described inrelation to FIG. 2. The disposable medical fluid line set 110 may beadapted to fluidly communicate with one or more medical fluid sources104 via the medical fluid delivery lines 112. In one approach, themedical fluid sources may be fluidly connected to the medical fluiddelivery lines 112 via couplers 113, as described below.

The medical fluid delivery lines 112 may be any well known type of fluidline used in medical applications, including fluid lines made ofmaterials such as plastic and silicon that are adapted for the deliveryof medical fluids. In one embodiment, a distal end of one or more of themedical fluid delivery lines 112 may comprise couplers 113, which may beused to selectively connect to the medical fluid sources 104. In anotherapproach, a proximal end of one or more medical fluid delivery lines 112is fluidly connected to a manifold 114. In one approach, the medicalfluid lines 112, 116 and manifold 114, as described above, may be moldedor formed as a single contiguous piece in fluid communication with eachother. Alternatively, the medical fluid lines 112, 116 and manifold 114may be separate pieces adapted to interface and fluidly communicate withone another. As used herein, medical fluid refers to any type of fluidthat may be used in the medical field including, without limitation,solutions comprising water and/or drugs, liquids, suspensions, gases andcombinations thereof.

In one aspect, one or more of the medical fluid delivery lines 112 maybe received by one or more valves 120. As discussed in further detailbelow, the valves 120 are adapted to control flow of medical fluidsthrough the medical fluid delivery lines 112, such as by opening,closing and achieving positions therebetween, to achieve first andsecond degrees of occlusion, for permitting and preventing flow ofmedical fluids to the patient during operation of the medical fluiddelivery system 102. In one approach, the valves 120 include firstinterface adaptations 134 for interfacing (e.g. matably receiving and/orengaging) with a valve operation system 140 of the present invention toaccomplish the first and second degrees of occluding of the medicalfluid flow. In one aspect, a first degree of occluding may substantiallyor completely occludes fluid flow through a medical fluid line. In oneaspect, a second degree of occluding may partially non-occlude (e.g.,impede) or completely non-occlude (allow) fluid flow through a medicalfluid line.

One embodiment of the interface of the medical fluid line set 110 withthe valve operating system 140 is depicted in FIG. 3. As noted, one ormore of the medical fluid delivery lines 112 may be received by one ormore valves 120. The one or more valves 120 may include first interfaceadaptations 134 for interfacing (e.g. matably receiving and/or engaging)with the valve operating system 140. In one approach, the firstinterface adaptations 134 may be protrusions, such as pins.

As used herein, “matably receiving” and like terms define a situationwhere the first interface adaptation is sized to receive, or be receivedby, a second interface adaptation, but the first and second interfaceare not necessarily in physical communication. In some instances, asdescribed in further detail below, it may be desirable to size the firstand second adaptations such that they may easily receive one another,but are not in physical communication in a first position.

Also, as used herein, “matably engaging” and like terms define asituation where the first interface adaptation is in physicalcommunication with said second interface adaptation, such as when thesecond interface adaptation has moved from a first position to a secondposition (e.g. via the valve controller) and is exerting a force on thefirst interface adaptation.

The valve operating system 140 generally comprises a valve controller,as described in further detail below, and a plurality of valve interfacemembers, which may comprise valve actuators 144. The valve actuators 144generally comprise second interface adaptations 145 for matablyreceiving and/or engaging with the first interface adaptations 134 ofthe valve 120 (e.g. via a male-female arrangement). In one approach, thesecond interface adaptations 145 may be openings, such as slots.

In one embodiment, the one or more medical fluid delivery lines 112 areinterconnected with (e.g. fixedly interconnected with) the valves 120and interfaced with the valve operation system 140, which includes valveactuators 144 which may interface with the valves 120. As will bediscussed in further detail below, the interface between the disposablemedical fluid line set 110 and the valve operation system 140, via thevalves 120 and the valve actuators 144, enables the medical fluiddelivery system 102 to deliver multiple medical fluids, either in serialor parallel, to a single patient using a single pumping system. Forexample, at least one first interface adaptation 134 may be engaged byat least one second interface adaptation 145, whereby the valveoperating system 140, via a valve controller, controls a force appliedto the at least one first interface adaptation 134 by the at least onesecond interface adaptation 145. This force causes at least one valve120 to move from a closed to at least a partially open position, andpermit fluid flow through one or more corresponding at least one medicalfluid delivery lines 112. In another approach, the first interfaceadaptations 134 may be engaged by the second interface adaptations 145,whereby the valve operating system, via a valve controller, controls aforce applied to the first interface adaptations 134 by the secondinterface adaptations 145, which causes the valve 120 to move from atleast a partially open position to a closed position, and substantiallyor completely occludes fluid flow through a corresponding medical fluiddelivery line 112.

In one approach, all the valves 120 of the medical fluid delivery system102 may be adapted to cooperatively interface with all of the valveactuators 144 of the medical fluid delivery system 102. For example, allthe valves 120 could be sized to matably receive and/or engage any ofthe valve actuators 144, and vice-versa. In one embodiment, all thevalves 120 comprise the same first interface adaptations 134 and all thevalve actuators 144 comprise the same second interface adaptations 145,wherein all the first interface adaptations 134 are sized to matablyreceive and/or engage any of the second interface adaptations 145.Further in this regard, all the recesses and/or ports within a housingof the medical fluid delivery system may be sized to receive any of thevalves 120, valve actuators 144, and/or medical fluid delivery lines112. Such an approach enables the valves 120 and valve actuators 144 tobe used interchangeably within the medical fluid delivery system 102,irrespective of location within the medical fluid delivery system andirrespective of which medical fluid is connected to a specific medicalfluid delivery line 112.

In another aspect, the medical fluid delivery lines 112, the valves 120,the valve actuators 144 and/or other components of the medical fluiddelivery system (e.g., portions of a housing such as recesses or ports)may include a human sensory engagement descriptor (e.g., a color code),such as by including a color designation located on the surface of suchitems. In this regard, certain colors may be utilized by (e.g., includedon the surface of) certain medical fluid delivery lines 112, valves 120valve actuators 144 and/or other components of the medical fluiddelivery system to correspond with one another and/or a certain medicalfluid (e.g., a certain drug solution). Thus, a user of the medical fluiddelivery lines 112, valves 120, valve actuators 144 and/or othercomponents of the medical fluid delivery system may be able to easilyconnect various component in relation to the color codes.

The medical fluid delivery system 102 of the present invention also mayinclude a pumping system 170 adapted to deliver medical fluids to apatient, which will now be described further in reference to FIG. 4. Thepumping system 170 generally comprises a bi-directional drive membermechanically interfaced with a pump drive member via a transmission fordriving the medical fluid pump. The bi-directional drive member,transmission and pump drive member are generally interfaced and adaptedsuch that movement of the bi-directional drive member in a firstdirection imparts a first output to the pump drive member, therebycausing a portion of it (e.g., the output shaft 190) to move in onedirection. The bi-directional drive member, transmission and pump drivemember are also generally interfaced and adapted such that movement ofthe bi-directional drive member in a second direction imparts a secondoutput to the pump drive member, also causing the pump drive member(e.g., the output shaft 190) to move in the same one direction.

For example, and as will be described in further detail below, thebi-directional drive member generally may comprise a bi-directionaldrive motor 172 mechanically interfaced with motor gear 174. The firstmotion transfer member may comprise a first gear 178 mechanicallyinterfaced with the motor gear 174 and a first one-way clutch 180,whereby operation of the bi-directional drive member in the firstdirection drives the first gear 178 and first one-way clutch 180 to movethe output shaft 190 in the one direction. The second motion transfermember may also comprise a second gear 182 mechanically interfaced withthe motor gear 174 and a second one-way clutch 184. However, whileoperation of the bi-directional drive member in the first directiondrives the second gear 182, the second one-way clutch 184 is interfacedwith the second gear 182 such that no significant motion is produced(e.g., the second one-way clutch 184 slips) and a mechanical output fromthe second motion transfer member is not imparted to the output shaft190.

Conversely, when the bi-directional drive member is operated in thesecond direction to produce the second output, the first gear 178 isdriven, but the first one-way clutch 180 is interfaced with the firstgear 178 such that no significant motion is produced (e.g., the firstone-way clutch 180 slips) and a mechanical output from the first motiontransfer member is not imparted to the output shaft 190. However, whenthe bi-directional drive member is operated in the second direction, thesecond gear 182 and a second one-way clutch 184 are driven, and amechanical output is provided from the second motion transfer member tothe output shaft 190 via the at least one additional transmission gear186 to drive the output shaft 190 in the same one direction.

As will be appreciated, the arrangement of the bi-directional drivemember, transmission and pump drive member enables the medical fluiddelivery system to operate over a wide range of speeds and correspondingfluid flow delivery rates using a single pump 200. As will be describedin further detail below, this novel arrangement can enable the deliveryof medical fluids over a wide variety of flow ranges, for example from0.1 ml per hour to 2000 ml per hour.

As noted above, the medical fluid delivery system 102 may include adisposable medical fluid line set 110, which may include valves 120,which are now described in further detail with reference to FIGS. 5 and6. Each valve 120 generally comprises elongated members 122, 126. Theelongated members 122, 126 are generally interfaced about one or morepivot points 130, and may be biased at one end by one or more biasingmeans 132, such as by one or more springs. In one approach, the biasingmeans 132 is included within the valve 120 such that the valve 120 is ina normally-closed position to substantially or completely occlude fluidflow through the medical fluid delivery line 112. In another approach,the biasing means is included within the valve 120 such that the valvein a normally open position to permit fluid flow through the medicalfluid delivery line.

In a particular embodiment, a first elongated member 122, may compriseat least one rib 124, and the second elongated member may comprise atleast one valley 126. In the normally-closed approach, the at least onerib 124 and at least one valley 128 are normally interfaced. In thisapproach, when a medical fluid delivery line 112 is received by thevalve 120, the at least one rib 124 and at least one valley 128 willpinch the medical fluid delivery line 112 such that fluid flow issubstantially or completely occluded. However, in an at least partiallyopen position, the at least one rib and 124 at least one valley 128 willat least not fully pinch the medical fluid delivery line 112, which maypermit some fluid flow through the medical fluid delivery line 112.

In the normally-open approach, the at least one rib 124 and at least onevalley 128 are normally not interfaced. In this approach, when a medicalfluid delivery line 112 is received by the valve 120, fluid flow will beat least partially non-occluded or completely non-occluded in a normallyopen position, but will be substantially or completely occluded in theclosed position by interface of the at least one rib 124 and at leastone valley 128 with the medical fluid delivery line 112.

In one embodiment, when the medical fluid delivery line 112 is pinchedby the at least one rib 124 and at least one valley 128, the medicalfluid delivery line 112 is contacted by the at least one rib 124 and atleast one valley 128 in at least three points. Contacting the medicalfluid delivery line 112 in at least three points may insure substantialor complete occlusion of fluid flow through the medical delivery line112, thereby preventing fluid flow to the patient P.

In another embodiment, the valve 120 may include guide members 136 forreceiving a medical fluid delivery line 112. The guide members 136 maybe used to retain the medical fluid delivery line 112 in the properplace within the valve 120.

In one aspect, at least one of the first and second elongated membersincludes first interface adaptations 134 for interfacing (e.g. matablyreceiving and/or engaging) with the valve operating system 140, asdescribed in further detail below. In one embodiment, the firstinterface adaptation 134 may be a protrusion or opening. In the case ofa protrusion, the first interface adaptation 134 may be a pin. In thecase of an opening, the first interface adaptations 134 may be a slot.As used herein, the terms opening and protrusion are used broadly todefine separate adaptations that complement each other such that theymay be matably received and engaged by one another.

In a particular embodiment, the valve 120 comprises first interfaceadaptations on opposing sides of at least one elongated member. As willbe appreciated, such an arrangement enables the valve 120 to beinterfaced with the valve actuator 144 in two orientations.

The interface of the valve 120 with the valve actuator 144 is nowdescribed in reference to FIG. 7A. As described above, the valve 120generally comprises first interface adaptations 134 for matablyreceiving and/or engaging second interface adaptations 145 of a valveactuator 144. In one approach, the first interface adaptations 134 maybe protrusions, such as pins, that are adapted to be received by thesecond interface adaptations 145 of the valve actuator 144. In thisapproach, the second interface adaptations 145 may be openings, such asslots, that are adapted to be received by the protrusions of the firstinterface adaptations 134. In another approach, the first interfaceadaptations 134 may be openings, such as slots, that are adapted to bereceived by the second interface adaptations 145 of the valve actuator144. In this approach, the second interface adaptations 144 may beprotrusions, such as pins, that are adapted to be received by theopenings of the first interface adaptations 134. In one aspect, thevalve 120 comprises at least two first interface adaptations 134 and thevalve actuator 144 comprises at least two second interface adaptations145 for matably receiving and/or engaging the at least two firstinterface adaptations 134.

In operation, and as will be described in further detail below, a valvecontroller 154 actuates the valve actuator 144, thereby causing thesecond interface adaptations 145 to engage the first interfaceadaptations 134. The engagement of the first interface adaptations 134by the second interface adaptations 145 results in a force on firstinterface adaptations 134. This force generally causes the biasing means132 to compress, which forces the biased ends of the elongated members122, 126 to be brought at least partially closer together. The otherends of the elongated members 122, 126 are consequently moved at leastpartially further apart from one another.

In one approach, ribs 124 and/or valleys 128 are located on thenonbiased ends of the elongated members 122, 126. In this approach, whenthe valve actuator 144 engages the first interface adaptations 134 viasecond interface adaptations 145 and forces the biased ends of theelongated members 122, 126 at least partially closer together, the ribs124 and/or valleys 128 are at least partially moved out of an interfacedposition, where some medical fluid may flow through the medical fluiddelivery line 112. This embodiment is generally known as anormally-closed valve approach, as described above. The utility of thisapproach will be appreciated in that any displacement, whetherintentional or accidental, of the valve 120 from the valve actuator 144will result in the valve 120 closing, thereby substantially orcompletely occluding fluid flow through the medical fluid delivery line112. Thus, any intentional or accidental displacement of the valve 120from the valve actuator 144 will result in the medical fluid deliverysystem 102 preventing medical fluid flow to the patient 106.

In another approach, ribs 124 and/or valleys 128 are located on thebiased ends of the elongated members 122, 126. In this approach, whenthe valve actuator 144 engages the first interface adaptations 134 viathe second interface adaptations 145 and forces the biased ends of theelongated members 122, 126 at least partially closer together, the ribs124 and/or valleys 128 are moved into an at least partially interfacedposition, where less or no medical fluid may flow through the medicalfluid delivery line 112. This embodiment is generally known as anormally-opened valve approach, as described above.

As noted above, the valve actuator generally comprises a secondinterface adaptation, which may comprise an opening or a slot. In aparticular embodiment, depicted in FIG. 7 b, the second interfaceadaptation 745 is a slot that includes a wide proximal end for matablyreceiving the first interface adaptation, a narrow distal end, and anarcuate path between the wide proximal end and the narrow distal end,where at least a portion of the path tapers from the wide proximal endto the narrow distal end. In this particular embodiment, the firstinterface adaptation is sized may be engage the slot and a point alongthe arcuate path.

The interface of the valve actuators 144 with the valve controller 154in the valve operating system 140 will now be described in reference toFIG. 8. Each valve actuator 144 is generally one component of a valveinterface member 142. Each valve interface member 142 may generallycomprise a valve actuator 144, an actuator return member 150, anactuator clutch 148 and actuator gear 146. The valve actuator 144 may bemechanically interfaced with an actuator return member 150 (e.g., atorsion spring), which may be interfaced with a stationary position 149.The actuator gear 146 is generally interfaced with an actuator clutch148.

The actuator gear 146 and actuator clutch 148 are generally interfacedsuch that motion of the actuator gear 146 in a first direction willengage the actuator clutch 148, thereby imparting motion to valveactuator 144 such that the valve actuator 144 is moved from a startingposition to a second position. Conversely, motion of the actuator gear146 in a second direction will not engage the clutch 148, and motion tovalve actuator 144 will not be imparted. It will be appreciated that theabove-referenced second position of the valve actuator may be anyposition of the full range of movement of the valve actuator 144,excluding the starting position.

The actuator return member 150 (e.g., a torsion spring) is generallymechanically interfaced with the valve actuator 144 via a hole 147 onthe valve actuator shaft, where a proximal end of the actuator returnmember is interlocked with the hole 147. The actuator return member 150is also generally mechanically interfaced with a stationary portion 149,where a distal end of the actuator return member 150 is interlocked witha portion of a stationary portion 149 (e.g., a hole in a housing).

In operation, when the actuator gear 146 is moved in a first direction,the actuator clutch 148 is engaged by the actuator gear 146 and thevalve actuator 144 is moved in corresponding relation thereto from astarting position to a second position. When the actuator gear 146 nolonger engages the actuator clutch 148, the actuator return member 150imparts a force on the valve actuator 144, thereby causing the valveactuator to return from the second position to the starting position.Thus, in relation to a valve 120, the second interface adaptations 145engage the first interface adaptations 134 when the actuator clutch 148moves the valve actuator 144, and act to operate the valve 120, asdescribed above. Moreover, when the actuator gear 146 no longer engagesactuator clutch 148, the second interface adaptations 145 of the valveactuator 144 no longer engage the first interface adaptations 134, andthe valve actuator 144 will be returned to a starting position by theactuation return member 150. Corresponding thereto, the valve 120 willalso be returned to a normally closed or normally opened position, asdescribed above. In one aspect, the valves 120 and valve actuators 144are interfaced such that the valves 1209 are loose in the startingposition.

With continued reference to FIG. 8, each valve interface member 142 isgenerally interfaced with the valve controller 154. The valve controller154 generally comprises a central motion transfer member and a pluralityof activation members 156. The central motion transfer member mayinclude a drive motor 158, a drive motor gear 159, a central drive gear160 and at least one additional central gear 162. The drive motor 158,motor gear 159 and central drive gear 160 are generally mechanicallyinterfaced such that motion of the drive motor 158 will be imparted tothe central drive gear 160 via the motor gear 159. In one aspect, thecentral drive gear 160 directly imparts mechanical motion to theplurality of activation members 156. In another aspect, the at least oneadditional central gears 162 may be provided to transfer mechanicalmotion from the central drive gear 160 to the plurality of activationmembers 156. Generally, the at least one additional central gear 162 isutilized to provide sufficient spacing between activation members 156,the valve interface members 142 and/or the central drive member.

Each of the activation members 156 generally comprises a lower section168. The lower section 168 of each of the activation members 156 isgenerally interfaced with the central motion transfer member (e.g., viathe central drive gear 160). In one approach, the lower section 168 ofeach activation member includes a plurality of teeth located about theperimeter of the lower section 168 for interfacing with a central drivegear 160. Thus, as the central motion transfer member moves in a firstdirection, each of the activation members 156 interfaced therewith willbe imparted motion (e.g., via lower sections 168 and central gear 160).In one approach, this motion is rotational motion.

Each of the activation members 156 generally also comprises an uppersection 166. The upper section 166 of each of the activation members 156generally comprises an “active” interface portion, adapted to interfacewith a corresponding actuator gear 146 during, at least, movement of theactivation member 156 from a first position to a second position. Theupper section 166 of each of the activation members 156 also generallycomprises a “inactive” interface portion, which will not interface withthe corresponding actuator gear 146 during, at least, movement of theactivation member 156 from a third position to a fourth position. In oneapproach, the active interface portion of the upper sections 166 may becontiguous. In another approach, the active interface portion of theupper sections 166 may be non-contiguous.

One embodiment of a valve operating system in accordance with thepresent invention is depicted in FIGS. 9 a-9 c. In this embodiment, eachof the activation members 956 a, 956 b is in the form of a mutilatedgear comprising an upper section 966 a, 966 b and a lower section 968 a,968 b, where each of the lower sections 968 a, 968 b are interfaced withthe central drive gear 960 via additional central gears 962. Thus, asthe central drive gear 960 moves, each of the activation members 956 a,956 b interfaced therewith, via lower sections 968 a, 968 b, will beimparted motion. In one approach, this motion is rotational motion.

As a central drive gear 960 moves in a first direction, each of theactivation members 956 a, 956 b interfaced therewith, via the additionalcentral drive gears 962, will also be moved. However, each of the uppersections 966 a, 966 b of each of the activation members 956 is generallypositioned within the valve controller in relation to a correspondingone valve interface member 942 a, 942 b, (e.g., via the above-describedactuator gears) such that less than all of the valve interface members942 will be activated in relation to a particular output of the centraldrive gear 960. That is, the active interface portion 967 a of a firstactive member 956 a is positioned within the valve controller 954 suchthat it may interface with a corresponding first valve interface member942 a during movement of the central drive gear 960 from a firstposition to a second controller position (e.g. a first motion output),and the active interface portion 967 b of a second active members 956 bis positioned within the valve controller 954 such that it may interfacewith a corresponding second valve interface member 942 b during movementof the central drive gear 960 from a third controller position to afourth controller position (e.g. a second motion output).

As used herein, the term “motion output”, in reference to the valvecontroller of the valve operating system, means of a portion of thevalve controller is interfaced with a portion of a corresponding valveinterface member, and may be imparting motion to the valve interfacemember. For example, a first motion output of the valve controller meansthe valve controller is interfaced with a corresponding first valveinterface member. A second motion output of the valve controller meansthe valve controller is interfaced with a corresponding second valveinterface member. In this regard, the valve controller may be interfacedwith the interface members, such that the motion outputs (e.g., firstand second motion outputs) are non-overlapping. Further, the firstmotion output and second motion output may result in coincidental motionof the first and second valve interface members, respectively.

Thus, as the first interface member 942 a is interfaced with the firstactivation member 956 a, its corresponding valve actuator 944 a will beactivated (e.g., actuated), and the corresponding valve associatedtherewith will be at least partially opened or closed, as describedabove. As the second interface member 942 b is interfaced with thesecond activation member 956 b, its corresponding valve actuator 944 bwill be activated (e.g., actuated), and the corresponding valveassociated therewith will be at least partially opened or closed, asdescribed above.

Referring back to FIG. 8, in one approach, the valve interface members142 and activation members 156 are arranged within the valve operatingsystem 154 such that the motion of a first interface member does notoverlap with the motion of a second interface member. That is, when afirst interface member is actuated via a first activation member (e.g.via a first motion output of the valve controller), thereby acting on acorresponding first valve via corresponding first valve actuator, asecond interface member is not actuated via its corresponding secondactivation member, thereby leaving a corresponding second valve in itsnormal position (e.g., a normally-opened or normally-closed position).

In another approach, the interface members 142 and activation members156 are sized and arranged within the valve controller 154 such that themotion of a first interface member partially overlaps with the motion ofa second interface member. That is, when a first interface member isactuated via a first activation member (e.g. via a first motion outputof the valve controller), thereby acting on a corresponding first valvevia corresponding first valve actuator, a second interface member isalso at least partially actuated via its corresponding second activationmember, thereby coincidentally also acting on its corresponding secondvalve via corresponding second valve actuator.

As will be appreciated, the central drive member and the valve interfacemembers may be sized and arranged in any configuration to achieve thedesired opening and closing of a plurality of valves in the medicalfluid delivery system of the present invention. For example, the valvecontroller may be configured to operate 2, 3, 4, 5, 6, 7, 8, 9, 10 oreven more valves (and any multiple thereof) associated with a medicalfluid delivery system, either in serial or parallel, and in anycombination, sequence or order. It will be appreciated that the numberof valve interface members will generally correspond to the number ofvalves desired to be operated. Thus, if the medical fluid deliverysystem requires the operation of 6 valves, 6 valve interface memberswould be generally be required, although different configurationsutilizing less or more valve interface members is possible.

Moreover, it will be appreciated that if it is desired to operate eachof the valves independently, the upper sections of 166 of the activemembers 156 should be sized, adapted and configured within the valvecontroller in relation to the number of valves associated with themedical fluid delivery system. Generally, this may be accomplished byrelating the number of valves desired to be opened to the full rotation(360°) of the central drive member. For example, if the medical fluiddelivery system is designed to operate two valves, then 180° (360°/2) ofrotation should be reserved by the central drive gear 160 for eachactive member 156. In such a case, the upper sections 166 of each of theactive members 156 would comprise active interface portions over notmore than half of the upper sections 166 and inactive interface portionsover no more than the other half of the upper sections 166.

In a medical fluid delivery system designed to operate 3 valves, then120° (360°/3) of rotation should be reserved by the central drive gear160 for each active member 156, and the upper sections 166 of each theactive members 156 should comprise active interface portions over nomore than one-third of the upper section 166.

In a medical fluid delivery system designed to operate 4 valves, then90° (360°/4) of rotation should be reserved by the central drive gear160 for each active member 156, and the upper sections of each activemembers should comprise active interface portions over no more than onequarter of the upper sections 166.

In a medical fluid delivery system designed to operate 5 valves, then72° (360°/5) of rotation should be reserved by the central drive gear160 for each active member 156, and the upper sections of each activemembers should comprise active interface portions over no more thanone-fifth of the upper sections 166.

In a medical fluid delivery system designed to operate 6 valves, then60° (360°/6) of rotation should be reserved by the central drive gear160 for each active member 156, and the upper sections of each activemembers should comprise active interface portions over no more thanone-sixth of the upper sections 166.

In a medical fluid delivery system designed to operate 7 valves, thenabout 51.4° (360°/7) of rotation should be reserved by the central drivegear 160 for each active member 156, and the upper sections of eachactive members should comprise active interface portions over no morethan one-seventh of the upper sections 166.

In a medical fluid delivery system designed to operate 8 valves, then45° (360°/8) of rotation should be reserved by the central drive gear160 for each active member 156, and the upper sections of each activemembers should comprise active interface portions over no more thanone-eighth of the upper sections 166.

In a medical fluid delivery system designed to operate 9 valves, then40° (360°/9) of rotation should be reserved by the central drive gear160 for each active member 156, and the upper sections of each activemembers should comprise active interface portions over no more thanone-ninth of the upper sections 166.

In a medical fluid delivery system designed to operate 10 valves, then36° (360°/10) of rotation should be reserved by the central drive gear160 for each active member 156, and the upper sections of each activemembers should comprise active interface portions over no more thanone-tenth of the upper sections 166.

As will be appreciated, the medical fluid delivery system may bedesigned to operate more than 10 valves, and corresponding calculationsas those provided above may be utilized to relate the number of valvesinterface members to the degrees of rotation required to be reserved bythe central transfer member, as well as the amount of active interfaceportions on the upper sections of each of the activation members.

Another aspect of enabling independent valve operation is thearrangement of the activation members 156 within the valve controller154 in relation to each other. As will be appreciated, if it is desiredto operate each valve independently, the upper sections 166 of each ofthe active members 156 should be arranged within the valve controllersuch that each upper section 166 engages their respective valveinterface member 142 over a specific range (e.g., 90°) of the entirerange (e.g., 360°) of the central transfer member. Moreover, as will beappreciated, the valve interface members, its valve activation membersand their relative components should be sized accordingly in relation tothe number of such members used in the valve control system.

For example, in a medical fluid delivery system comprising four valves,the upper section 166 of a first activation member should engage thefirst valve interface member over a first quarter of movement of thecentral transfer member (e.g., the first 90° of rotation of a centraldrive gear 160). The upper section 166 of a second activation membershould engage the second valve interface member over a second quarter ofmovement of the central transfer member (e.g., the second 90° ofrotation of a central drive gear 160). The upper section 166 of a thirdactivation member should engage the third valve interface member over athird quarter of movement of the central transfer member (e.g., thethird 90° of rotation of a central drive gear 160). The upper section ofa fourth activation member should engage the third valve interfacemember over a fourth quarter of movement of the central transfer member(e.g., the fourth 90° of rotation of a central drive gear 160). As notedabove, in such an embodiment, each of the upper sections 166 shouldcomprise active interface portions over no more than a quarter of theirrespective upper sections 166. This arrangement will enable theactuation of each of the four valves independently from each other. Itwill be appreciated that similar arrangements for medical fluid deliverysystems comprising 2, 3, 5, 6, 7, 8, 9, and 10 or more valves may beimplemented using the above-referenced methodology.

In another approach, the medical fluid delivery system may be configuredwith a valve operating system that enables two or more valves to beoperated simultaneously. It will be appreciated, that variations of theabove-described methodology may be employed to achieve such simultaneousvalve operation. For example, in a medical fluid delivery systemcomprising 4 valves, the valve operating system could be adapted suchthat first and second valves open simultaneously and independently ofthe opening of the third and fourth valves, which may or may not opensimultaneously. In such a case, the first and second activation membersmay be identical and arranged within the valve operating system, suchthat their respective upper active members each engage their respectivevalve interface members over a first portion of movement of the centraltransfer member (e.g., the first 120° of rotation of the central drivegear 160). Likewise, the third activation member may be adapted andarranged within the valve operating system such that its upper activemember engages its respective valve interface member over a secondportion of movement of the central transfer member (e.g., the second120° of the rotation of the central drive gear 160). The fourthactivation member may be adapted and arranged within the valve operatingsystem such that its upper active member engages its respective valveinterface member over a third portion of movement of the centraltransfer member (e.g., the third 120° of rotation of the central drivegear 160). It will be appreciated that similar arrangements for medicalfluid delivery systems comprising 2, 3, 5, 6, 7, 8, 9, and 10 or morevalves may be implemented using the above-referenced methodology toachieve simultaneous valve operation.

As noted, the central motion transfer member may comprise a drive motor158 to impart motion to each of the active members of the valvecontroller. In one embodiment, the drive motor 158 of the valvecontroller 154 is a unidirectional drive motor adapted to impart motionto the central drive gear 160 via the motor gear 159, whereby thecentral drive gear 160 may be driven in one direction. In anotherembodiment, the drive motor 158 of the valve controller 154 is abi-directional drive motor adapted to impart motion to the central drivegear 160 via the motor gear 159, whereby the central drive gear 160 maybe driven in two directions.

In one aspect, the drive motor 158 is a bi-directional motor and thevalve controller comprises components to enable selective operation ofeach valve interface member without operating at least one other valveinterface member. As noted above, the actuator gear 146 and actuatorclutch 148 are adapted such that movement (e.g., rotation) of theactuator gear 146 in one direction engages the actuator clutch 148, butmovement (e.g., rotation) of the actuator gear 146 in a second directiondoes not engage the actuator clutch 148. This arrangement isparticularly useful when operating the valve controller 154 toselectively operate a selected valve interface member 142.

For example, as the bi-directional drive motor of the valve controller154 moves (e.g., rotates) its motor gear 158 in a first direction (e.g.,counterclockwise rotation), a first direction of movement is imparted toeach of the actuator gears 146 by their respective activation members156. In this first direction of movement, the actuator gears 146 andactuator clutches 148 may be arranged such that they do not engage oneanother. However, as the bi-directional drive motor of the valvecontroller 154 moves (e.g., rotates) its motor gear 158 in a seconddirection (e.g., clockwise rotation), a second direction of movement isimparted to each of the actuator gears 146 by their respectiveactivation members 156. In this second direction of movement, theactuator gears 146 and actuator clutches 148 may be arranged such thatthey engage one another, thereby imparting motion to their associatedvalve interface members as the bi-directional motor rotates its motorgear 158 about its full range of second direction motion (e.g.,clockwise rotation). Thus, to prevent opening one or more valves (e.g.,so that medical fluids may not be inadvertently delivered to a patient),it may be desirable to operate the bi-directional motor in the firstdirection until a specific point is reached, at which time thebi-directional motor is operated in a second direction to open aspecific valve or valves, as described in further detail below.

As described above, as the bi-directional drive motor moves in the firstdirection, each of the actuator gears 146 will be moved in a firstdirection of movement once they have interfaced with the upper sections166 of the activation members 156. As the bi-directional drive motorcontinues to move in the first direction, the actuator gear 146 will nolonger be moved in a first direction of movement once the activeinterface portions of the upper section 166 have moved outside the scopeof interface. Thus, stopping the bi-directional motor at a locationafter the active interface portion of the upper section 166 has movedoutside the scope of interface with the actuator gear 146, and thenmoving the bi-directional motor in the second direction will result inoperating the corresponding valve interface member to open only thecorresponding valve.

In one approach, the bi-directional motor stops moving in the firstdirection just proximal to the scope of interface between the activeinterface portion of the upper section 166 and actuator gear 146. Insuch an approach, the bi-directional motor is then moved in a seconddirection to activate the corresponding first interface member 142, andits corresponding valve actuator 144 and valve 120. In this regard, avalve status determination system may be employed with the valveoperating system to selectively control the valves of a medical fluiddelivery system of the present invention. It will be appreciated thatthis selective open methodology could be employed with any number ofvalves and valve interface members depending on the desired arrangementof the valve operating system, as described above. Thus, the medicalfluid delivery system of the present invention may be adapted toselectively open one or more valves without opening at least one othervalve within the medical fluid delivery system.

In one embodiment, the medical fluid delivery system is operativelyinterfaced with a valve status determination system, which comprises thenecessary components to determine when a portion of each of the valveinterface members 142 (e.g., each actuator gear 146) is interfaced witha corresponding activation member 156. Thus, the valve statusdetermination system is operable to help achieve the above describedselective valve opening, as will now be described in relation to FIG.10.

As depicted in FIG. 10, a medical fluid delivery system may comprise adisposable medical fluid line set 110 interfaced with a valve operatingsystem 140. The medical fluid delivery system may also comprise a valvestatus determination system, which may comprise components integratedwith the valve operating system 140 for the determination of theposition of the various components of the valve operating system 140. Inone approach, a microswitch 220 for each valve actuator is provided andis adapted to interface with a terminal portion of a corresponding valveactuator 144. In one embodiment, the at least one microswitch 220 is incommunication (e.g., mechanical, electrical, magnetic and/or opticalcommunication) with a terminal portion of the corresponding valveactuator 144 when the valve actuator 144 is in a first position.Conversely, the at least one microswitch 220 is not in communicationwith a terminal portion of the corresponding valve actuator 144 when thevalve actuator 144 is a second position. The at least one microswitch220 may also be in communication (e.g., mechanical, electrical, magneticand/or optical communication) with other microswitches 220, so that themicroswitches 220 may communicate with one another. In one embodiment,the microswitches 220 are interfaced with a communicative connector 224,which may be interfaced with a processor. The processor may be utilizedin conjunction with the microswitches 220 to enable selective activationof valves, as described above.

In operation, when at least one microswitch 220 is in communication witha terminal portion of the a corresponding valve actuator 144, it maysend signals to the other microswitches 220 and/or communicativeconnector 224 to communicate the position of the valve associated withthe microswitch. In one aspect, the medical fluid delivery system may beconfigured such that when a terminal portion of a valve actuator 144 isin communication with a corresponding microswitch 220, the communicationmay indicate the corresponding actuator gear 146 position.

In another aspect, the valve status determination system may also oralternatively comprise microswitches 222 adapted to interface with aterminal portion of a shaft utilized in the activation members 156. Inone embodiment, at least one microswitch 222 is in communication (e.g.,mechanical, electrical, magnetic and/or optical communication) with aterminal portion of a shaft of the corresponding activation member 156when the activation member 156 is in a first position. Conversely, theat least one microswitch 222 is not in communication with a terminalportion of a shaft of the corresponding activation member 156 when theactivation member 156 is a second position. The at least one microswitch222 may also be in communication (e.g., mechanical, electrical, magneticand/or optical communication) with other microswitches 222, so that themicroswitches 222 may communicate with one another. In one embodiment,the microswitches 222 are interfaced with a communicative connector 224,which may be interfaced with a processor. The processor may be utilizedin conjunction with the microswitches 222 to enable selective activationof valves, as described above.

In operation, when at least one microswitch 222 is in communication witha terminal portion of the shaft of a corresponding activation member156, it may send signals to the other microswitches 222 and/orcommunicative connector 224 to communicate the position of itscorresponding activation member 156. In one aspect, the medical fluiddelivery system may be configured such that when a terminal portion ofthe shaft of an activation member 156 is in communication with acorresponding microswitch 222, the communication may indicate theposition of the corresponding upper section 166 of the activation member156.

In another aspect, microswitches 220 and 222 may be utilized together todetermine the relative positions of each of the actuator gears 146 andupper sections 166 of activation members 156. The use of themicroswitches 220, 222, either alone or in combination, in conjunctionwith a processor, may help the medical fluid delivery system toaccomplish the selective opening of individual valves, as describedabove.

In another embodiment, the valve status determination system maycomprise a single sensor operatively interfaced with the central motiontransfer member. In this regard, the central motion transfer member maybe operable to move over a range of motion (e.g., a full circle, such asin relation to a central drive gear). The single sensor may be adaptedto sense the relative position of the central drive member in relationto the range of motion (e.g. the relative position of the central drivegear in relation to a full circle). As the activation members of thevalve controller move in corresponding relation to the motion of thecentral drive member, the sensed position of the central drive membermay be used to calculate the relative positions of the valve activationmembers and/or valve interface members.

The medical fluid delivery system 102 of the present invention may alsoinclude a pumping system 170, which may include a transmission of thepresent invention. Referring now to FIG. 11 a, one embodiment of atransmission useful in accordance with the pumping system 170 of thepresent invention is depicted. The transmission generally comprises afirst motion transfer member (e.g., a first gear 178 and first one-wayclutch 180) mechanically interfaced with a bi-directional drive member(e.g., a bi-directional drive motor 172 and a motor gear 174). Thetransmission also generally comprises a second motion transfer member(e.g., a second gear 182, a second one-way clutch 184, and at least oneadditional transmission gear 186). Both the first motion transfer memberand the second motion transfer member may be mechanically interfacedwith the bi-directional drive member and a portion of a pump drivemember (e.g., an output shaft 190) for imparting motion to the pumpdrive member.

The first motion transfer member of the transmission may be any type ofdevice that is adapted to receive and transfer the mechanical output ofthe bidirectional drive member to the pump drive member, as describedabove. In one approach, the first motion transfer member includes one ormore gears, which may be mechanically interfaced with one or moreclutches. In the depicted embodiment, the first motion transfer memberincludes a first gear 178 mechanically of this of with a motor gear 174and a first one-way clutch 180 (hidden in this embodiment). The firstone-way clutch 180 is mechanically interfaced with an output shaft 190,which is mechanically interfaced with the pump, as depicted previouslyin FIG. 4.

The second motion transfer member of the transmission may be any type ofdevice that is adapted to transfer the mechanical output of thebi-directional drive member to the pump drive member, as describedabove. In one approach, the second motion transfer member includes oneor more gears, which may be mechanically interfaced with one or moreclutches. In the depicted embodiment, the second motion transfer memberincludes a second gear 182 mechanically interfaced with a motor gear 174and a second one-way clutch 184. The second one-way clutch ismechanically interfaced with the output shaft 190 via a series of atleast one additional transmission gears 186. In one embodiment, thesecond motion transfer member also includes a third one-way clutch 188,as described in further detail below.

The bi-directional drive member may be any mechanical or electricaldevice capable of imparting motion to the first motion transfer memberand second motion transfer member. In the depicted embodiment, thebi-directional drive member includes a bi-directional motor 172 and amotor gear 174. The bi-directional motor 172 is mechanically interfacedwith the motor gear 174 and is capable of moving the motor gear 174 in afirst direction to impart a first output to of the first motion transfermember and second motion transfer member. The bidirectional motor 172 isalso capable of moving the motor gear 174 in a second direction toimpart a second output to the first motion transfer member and secondmotion transfer member. In one approach, the bi-directional drive motor172 is a DC iron-less core motor, with or without an integral geartrain, adapted to provide a wide range of output speeds to the motorgear 174 in both the first and second directions. In one embodiment, asdescribed in greater detail below, the bi-directional drive motor 172 isin communication with a processing system to control the speed ofrotation of motor gear 174, and correspondingly, the pump drive memberand pump.

The pump drive member may be any device capable of receiving motion fromeither of the first motion transfer member or the second motion transfermember and transferring at least a portion of such motion to a pump.Referring back to FIG. 4, the pump drive member may comprise an outputshaft 190, an output worm gear 192, and a mating pump worm gear 194. Inone approach, the output shaft 190 is mechanically interfaced with thefirst and second motion transfer members and receives the output fromsuch first and second transfer members. The output shaft 190 may bemechanically interfaced with the output worm gear 192, which ismechanically interfaced with the mating pump worm gear 194. As theoutput shaft moves (rotates) in the one direction, the output worm gear192 may impart motion to the pump via the mating pump worm gear 194 andthe pump shaft 196.

Operation of the transmission will be described in reference to FIGS. 11a and 11 b, which uses a system of gears and one-way clutches. However,it will be understood that, as noted above, the first motion transfermember and second motion transfer member could comprise the use of anyone of the listed motion transfer mechanisms.

Referring now to FIG. 11 a, in operation, as motor gear 174 is moved(e.g., rotated) in a first direction by the bidirectional motor 172(e.g., counterclockwise as depicted by the arrow), the motor gear 174creates a first output, in the form of mechanical motion, and transfersthe first output to the first gear 178 and second gear 182. Both firstgear 178 and second gear 182 are consequently moved (e.g., rotated abouttheir axis) in response to the first output (e.g., both gears arerotated in the clockwise direction). In this direction of movement(e.g., rotation), first gear 178 and first one-way clutch 180 aremechanically interfaced such that first gear 178 engages first one-wayclutch 180 when receiving the first output, and first one-way clutch 180imparts the first output to the output shaft 190 and moves (e.g.,rotates) it in one direction (e.g., clockwise) at a first speed.However, second gear 182 and second one-way clutch 184 are mechanicallyinterfaced such that second gear 182 does not engage second one-wayclutch 184 when receiving the first output. Therefore, the first outputreceived by the second gear 182 is not imparted to the output shaft 190via the second one-way clutch 184 and the at least one additionaltransmission gear 186.

Referring now to FIG. 11 b, conversely, when motor gear 174 is moved(e.g., rotated) in a second direction (e.g., clockwise as depicted bythe arrow) by the bi-directional motor 172, the motor gear 174 creates asecond output of, in the form of mechanical motion, and transfers thesecond output to the first gear 178 and second gear 182. Both first gear178 and second gear are consequently rotated about their axis inresponse to the second output (e.g., both gears are rotated in thecounterclockwise direction). In this direction of rotation, first gear178 and first one-way clutch 180 are mechanically interfaced such thatthe first gear 178 does not engage first one-way clutch 180 whenreceiving the second output. However, second gear 182 and second one-wayclutch 184 are mechanically interfaced such that second gear 182 doesengage second one-way clutch 184 when receiving the second output. Thesecond one-way clutch 184, therefore, engages the at least oneadditional transmission gear 186, for example via a pinion shaft, andimparts motion to (e.g., drives) the output shaft 190. The output shaftand the at least one additional transmission gear 186 are arranged withthe second one-way clutch 184 and second gear 182 such that the outputshaft 190 is rotated in the same one direction (e.g., clockwise) as wascreated with the first output from the bidirectional drive member, butat a second speed.

As noted above, the first motion transfer member and second motiontransfer member may comprise a system of gears and one-way clutches.Referring now back to FIG. 4, in one embodiment, due to the arrangementof the at least one additional transmission gear in the second motiontransfer member, as the output shaft 190 rotates in the one direction,the at least one additional transmission gear 186 also rotates,irrespective of whether the bidirectional drive member is moving in afirst direction or second direction. In some embodiments, such anarrangement may require additional considerations. As will beappreciated, the gears of the first motion transfer member and secondmotion transfer member should be sized and arranged to avoid a bindingsituation, such as would occur if the first output resulted in theoutput shaft moving the at least one additional transmission gear 186and corresponding second one-way clutch 184 (e.g., via a pinion shaft)in one direction faster than the rotation of slip of the second one-wayclutch 184. Additionally, extra power may be required to overcome themechanical energy utilized to rotate the at least one additionaltransmission gear 186 during the first output.

Referring back to FIGS. 11 a and 11 b, in another aspect of thetransmission of the pumping system, the second motion transfer membermay comprise a third one-way clutch 188 mechanically interfaced with theoutput shaft 190 and one of the at least one additional transmissiongear 186. The third one-way clutch 188 may be integrated in thetransmission such that when the output shaft 190 moves at a certainspeed, the third one-way clutch 185 will slip, where no substantialmotion is imparted to the at least one additional transmission gear 186in response to the first output. As will be appreciated, benefits fromutilizing the third one-way clutch 188 include reduced powerrequirements and reduced noise as the at least one additionaltransmission gear 186 will not be moved. Also, the transmission may havean increased lifetime and a reduced probability of failure as the amountof movement of the gears within the system will be reduced.

As noted above, both the first output and second output result inmovement of the pump drive member in the one direction. The speed ofmovement (e.g., rotation) of the pump drive member (e.g., output shaft190) in the one direction in response to the first output (i.e., thefirst speed) may be the same or different than the speed of movement(e.g., rotation) of the pump drive member in the one direction inresponse to the second output (i.e., the second speed). In one approach,the second speed of the pump drive member (e.g. output shaft 190) isless than the first speed. In another approach, the second speed of thepump drive member (e.g. output shaft 190) is greater than the firstspeed.

Thus, the pump of the medical fluid delivery system of the presentinvention may be driven in a single direction by a bidirectional drivemember (e.g., a bi-directional motor 172) at various speeds,irrespective of whether the bi-directional drive member is moving in afirst or second direction. The benefits of such a system will beappreciated by those skilled in the art. For example, the components ofthe pumping system (e.g., the bi-directional drive member, transmissionand drive pump drive members) may be chosen, arranged and interfacedwith the pump to enable the pump to deliver medical fluids to a patientover a wide range of flow rates. For example, the gear ratios of each ofthe first and second motion transfer members may be chosen to drive thepump drive member over a wide range of speeds such that the pumpingsystem is adapted to provide medical fluid flow to a patient over a widerange of flow rates. In one embodiment, the pumping system is adapted toprovide medical fluid flow to a patient in the range of 0.1 ml per hourto 2000 per hour. More particularly, the pumping system may be adaptedto provide medical fluid flow to a patient in the range of 0.1 ml perhour 1000 ml per hour.

In one approach, the bi-directional drive member may be moved at a widerange of speeds (e.g., by changing the supplied current and/or voltageto electric bidirectional drive motor) and/or operated at intermittenttimes in both the first and second directions, thereby enabling thefirst and second outputs to vary in response thereto. Such speedvariation and/or intermittent pump operation, thus, enables a pumpinterfaced with such bi-directional drive member to deliver medicalfluids over a wide range of flow rates in corresponding relation to thefirst and second outputs. In one approach, the first and second motiontransfer members are chosen and arranged with the bi-directional drivemember and pump drive member such that at least one, and in someinstances each, is capable of changing the fluid delivery rate of thepump by a factor of up to 1000× (e.g., 2×, 3×, 4×, 5×, 10×, 25×, 50×,75×, 100×, 250×, 500×, 750× and 1000×) in corresponding relation tospeed changes and/or changes in time of operation (e.g., more or lessintermittent or continuous) of the bi-directional drive member.

In another approach, the first and second motion transfer members arechosen and arranged with the bidirectional drive member and pump drivemember such that the first output corresponds to a maximum medical fluiddelivery rate that is up to 1000 times greater (e.g., 2×, 5×, 10×, 20×,50×, 100×, 250×, 500× and 1000×) than the maximum medical fluid deliveryrate that corresponds to the second output. In one aspect, the firstoutput corresponds to a medical fluid delivery rate of between 10 ml perhour and 1000 ml per hour, and the second output corresponds to amedical fluid delivery rate of between 0.1 ml per hour and 10 ml perhour. In another aspect, the first output corresponds to medical fluiddelivery of between 100 ml per hour and 2,000 ml per hour, and thesecond output corresponds to medical fluid delivery rate of between 1 mlper hour and 100 ml per hour. As will be appreciated, the first outputand second output could be rearranged such that the first outputcorresponds to the lower fluid delivery rate and the second outputcorresponds to the higher fluid delivery rate.

The pumping system of the present invention may also include a pumpspeed determination system to enable a determination of the speed of thepump. In one embodiment, the pump speed determination system comprisesthe use of an encoder, as described above, and as will now be describedin reference to FIG. 12. The pump and the pump speed determinationsystem may include a pump drive member (e.g., an output shaft 1290,output worm gear 1292, mating worm gear 1294) mechanically interfacedwith the 1200 pump (not shown) via a pump drive shaft 1296. The pumpdrive member may also include components for calculating the speed ofrotation of the pump head. The pump speed determination system mayfurther include at least one encoder and an electrical output line to1295. The at least encoder 1291 is generally in communication theelectrical output line 1295.

In one approach, the at least one magnet is used as the encoder 1291 andincludes four magnets equally positioned about the output shaft 1290. Areed switch 1293, which may contain two switches approximately 45°rotationally apart, maybe in magnetic vacation with the magnetic encoder1291.

The pumping system 170 of the medical fluid delivery system of thepresent invention may be any device adapted for the moving medical fluidto the patient. For example, the pumping system 170 may operate throughchanges in pressure and/or gravity, such by using a rotary peristalticpump, linear peristaltic pump centrifugal pump, diaphragm pump or pistonpump.

In one embodiment, the pumping system 170 comprises a rotary peristalticpump, as is now further described in relation to FIG. 13. A rotaryperistaltic pump 1300 generally comprises a pump head 1303, whichcomprises pinch members 1302, which comprise a pinch-roller 1304, apinch-spring 1306 and a pinch-roller shaft 1308. The pinch members 1302may be equally spaced around the pump head 1303 and may rotate about thepinch roller shafts 1308 on a sleeve bearing to pinch a medical fluidline against an anvil surface (not shown). The pinch members 1304 may bedesigned to substantially or completely occlude the medical fluid lineagainst the anvil, and, therefore, the pinch members 1304 may have theability to account for system tolerances of different medical fluid linesets. In one aspect, the pinch-rollers 1304 may be biased away from thecenter of head rotation by a pinch-spring 1306 (e.g., a coil torsionspring), which may retain the pinch-roller 1304 on the pinch-rollershaft 1308. The pinch-springs 1306 provide a motive force for pushingthe pinch-rollers 1304 toward the outer perimeter (e.g., circumference)of the pump head 1303, which acts to pinch the pinch-rollers 1304against the medical fluid line and the anvil surface. The pinch members1302 may also be allowed to slide an amount slightly more than thesystem tolerances utilizing the holes 1310. Thus, the pinch members maybe able to move toward and away from the anvil and the medical fluidline contained in the pump head, which receive the pinch-roller shafts1308. In operation, as the pump head 1303 rotates, the pinch members1302 pinch the medical fluid line against the anvil, and any medicalfluid within the medical fluid line will be forced, (e.g., via motiveand pressure head forces) through the line in the direction of movementof the pump head, as is well known in the art.

In one embodiment, rotation of the pinch members in a first directionmoves medical fluid from one or more of the medical fluid delivery linesto a medical fluid output line, such as to a patient, as describedabove. In an alternate embodiment, rotation of the pinch members in asecond direction moves medical fluid from a medical fluid output line toat least one medical fluid delivery line. Rotation of the pinch membersin this second direction would enable distribution of a medical fluidinto multiple receptacles, for example.

Placement of the medical fluid line within the pump head may beaccomplished via any known means, such as removal of a portion the topof the pump head, followed by subsequent replacement of the portion ofthe pump head. In one aspect of the present invention, the medical fluiddelivery line system comprises a cover interfaced with the pump toenable movement of at least a portion of the pump so that a medicalfluid line may be placed or removed without removing of any of the partsof the pump.

Referring now to FIGS. 14 a-14 d, one embodiment of a medical fluiddelivery system including a moveable portion for placement and removalof a medical fluid line is depicted. In this embodiment, the anvil 1410of a pump is movable to allow initial placement of the medical fluidline 1416 in the channel of the pump head 1420. In one aspect, the anvil1410 may be mechanically coupled to the motion of an angular element, inthis embodiment, a cover 1430, such that as the cover 1430 rotates abouttwo hinge points (e.g., approximately 100 degrees), the anvil 1410 isdrawn away from the pinch members, thereby allowing placement of amedical fluid line 1418. When the cover 1430 is closed, the anvil 1410moves back towards the pinch members and the medical fluid line may bepinched therebetween, as described above. A latch 1431 may be used tomaintain the cover in a closed position.

In a particular embodiment, the coupling of the motion of the cover 1430is pivotally connected to the medical fluid delivery system housing 1440by one or more hinges. The cover 1430 may contain a partial internalgear ring 1450 adjacent to the hinge point(s) 1445, which is arranged tomechanically interfaced with a anvil gear 1460 on the anvil shaft 1470.The anvil gear 1460 of the anvil shaft 1470 is chosen to have a pitchdiameter smaller than the internal ring gear 1450 of the cover 1430. Theratio of the internal gear ring 1450 to the anvil gear 1460 should bearranged and interfaced such that movement of the internal gear ring1450, via the cover 1430, moves the anvil 1410 an amount necessary toenable placement of the medical fluid line within the pump. For example,the internal gear ring 1450 and anvil gear 1460 may be arranged andinterfaced such that 100 degrees of rotation of the cover 1430 rotatesthat anvil shaft 1470 approximately 200 degrees.

In one aspect, the anvil shaft 1470 may be constrained in the directionof rotation by a rotational sleeve bearing 1471. Further, the anvil mayalso be mechanically engaged to an offset portion of the anvil shaft1470 by an engaging sleeve bearing 1473. The engaging sleeve bearing1473 may be arranged to contact the anvil 1410 such that the angular(e.g., rotary) motion of the anvil shaft 1470 results in a linear motionfor the anvil 1410. In another approach, the anvil shaft 1470 may alsobe arranged to rotate approximately 20 degrees past maximum displacementto provide a method of self-holding the anvil 1410 and pump cover 1430in the open position.

In one embodiment, a biasing means 1475 (e.g., a spring) may be used tobias the anvil 1410 in a desired direction to maintain its positionwithin the pump head 1420. Thus, the biasing means 1475 may help ensurethat the medical fluid line 1416 is properly arranged within the pumphead 1420 (e.g., in physical communication with the anvil and pumprollers, described above) so that the pump deliver medical fluids, asdescribed above.

In a particular embodiment, a cantilever force beam 1491 is mechanicallyattached to the anvil 1410 such that as the anvil 1410 slides towardsthe pump head 1420, the end of the cantilever force beam 1491 contactsthe medical fluid line 1416 at a point downstream from the pump head1420. This contact may compress the medical fluid line 1416 at the pointof contact. Pressure inside the medical fluid line causes the cantileverforce beam to move in a substantially linear fashion. The movement ofthe cantilever force beam in response to the pressure profile within themedical fluid line may be coupled to a sensor and/or processor tostatically or dynamically collect pressure information about the medicalfluid line 1416. For example, the processor may utilize the pressureinformation to determine whether the pump is operating correctly (e.g.,whether a fluid reservoir is empty or whether a line is blocked). In oneaspect, the processor may determine whether the pump is operatingcorrectly by comparing the measured pressure profile of the medicalfluid delivery line to a known pressure profile.

In another aspect, the pressure inside the medical fluid line may bemeasured using a force sensor (e.g., a piezoelectric sensor) locateddownstream of the pump in physical communication with the medical fluidoutput line 1416, such as those supplied by Honeywell International,Inc. (Morristown, N.J., U.S.A.), (e.g., a Model 1865 Force Sensor). Asis known by those in the art, the force sensor may be communicativelycoupled to a processor to collect pressure information about the medicalfluid output line 1416.

The medical fluid delivery system of the present invention may includeany one of the above described components and in any combination. In oneapproach, the medical fluid delivery system may simply comprise a singlemedical fluid line interfaced with a pump. In one aspect of thisapproach, the medical fluid line may be received by a valve of thepresent invention. In an additional aspect of this approach, the medicalfluid line maybe interfaced with a valve operating system of the presentinvention via the valve. In yet another embodiment of this approach, thepump may comprise a pumping system of the present invention.

In another embodiment, the medical fluid delivery system may comprise adisposable medical fluid line set interfaced with a pump, where thedisposable medical fluid line set comprises a plurality of medical fluiddelivery lines. In one aspect of this embodiment, at least one of theplurality of medical fluid delivery lines may be received by at leastone valve of the present invention. In another aspect of thisembodiment, the disposable medical fluid line set may be interfaced witha valve operating system of the present invention. In yet an additionalapproach to this embodiment, a pumping system of the present inventionmay be interfaced with the disposable medical fluid line set.

In one embodiment, the medical fluid delivery system comprises all of adisposable medical fluid line set, at least one valve, a valve operatingsystem and a pumping system, as depicted in FIGS. 15 and 16. In such anembodiment, the medical fluid delivery system comprises a disposablemedical fluid line set 110 interfaced with a valve operating system 140and a pumping system of the present invention, each contained within asingle housing 1440. However, any of the components of the medical fluiddelivery system may be interfaced with one another without using ahousing or using a plurality of housings.

One embodiment of the speed range in relation to the motor armature isdescribed below and in reference to FIGS. 17 a and 17 b. Variousembodiments of a pump speed determination system are also describedbelow in relation to FIGS. 18 a and 18 b. In reference to FIGS. 17 a, 17b, 18 a and 18 b, the terms “clockwise” and “counterclockwise” are usedfor illustration purposes, but such terms are used only for the purposesof illustration, and are not meant to be limiting in any fashion.

FIG. 17 a depicts the motor speed versus desired flow for movement of amotor in a first direction (e.g., clockwise) and movement of the motorin a second (e.g., counterclockwise) direction. The first solid line (asmoving across the page left to right) shows the counterclockwise motorspeed is held constant at 1500 rpm for flow ranges from 0.1 to 25 ml/hr.The first dashed line is the counterclockwise motor duty cycleassociated with that flow rate. In this embodiment, the duty cycle isless than 10% for flow rates less than 2 ml/hr. In one aspect, thecounterclockwise motor speed may be constant at about 1500 rpm relatingto a fluid delivery rate of 0.1 to 25 ml/hr, and the duty cycle may beincreased to achieve the desired flow. To deliver 25 ml/hr to 100 ml/hr,the rpm and/or duty cycle may be increased to achieve the selected flow.At approximately 50 m/hr or higher, the flow may be achieved fromclockwise rotation of the motor. In one aspect, the clockwise motorspeed may be maintained at about 3000 rpm to deliver from 50 to 400ml/hr, again with a variable duty cycle. To achieve from about 400 ml/hrto 1000 ml/hr, the motor speed and/or duty cycle may be increased. Inone aspect, the maximum motor speed may be about 5500 rpm, which mayinclude a duty cycle of 99%.

The time to change between the fluid lines may consume pumping time andreduce the available duty cycle and/or fluid delivery rate. FIG. 17 bdepicts one embodiment of a 4 fluid line system. As shown, two lines maybe limited to a fluid delivery rate of 800 mL/hr, three lines may belimited to a fluid delivery rate of 650 ml/hr, and four lines may belimited to a fluid delivery rate of 500 mL/hr.

In one embodiment of the pump speed determination system, a Hall effectsensor is used to monitor the rotation of the 50-tooth worm gearattached to the pump head shaft. This gives a (360/50) 7.2 degree perpulse resolution. For example, at a 1000 ml/hr flow rate, the sensoroutput frequency is 47 Hz or 2820 cycles per min, which will require anelectrical sensing of 2820 cycles per min +/−28 cycles to achieve a+/−1% control accuracy. At a clockwise speed of 3000 rpm, the frequencyoutput may be reduced to 26 Hz and +/−15 cycles per min to achieve a 1%control accuracy.

FIG. 18 a is a chart depicting one embodiment of a minimum motor speedverses time in the clockwise direction. In one embodiment, at a minimumclockwise speed, one motor pulse would be greater than the 15 cycles/minfor accuracy purposes. Therefore, in one embodiment, a processor andassociated circuitry may intermittently drive the pump motor in thecounterclockwise direction to achieve a correct number of sensor pulses.For example, if at the end of a clockwise delivery pulse in a 30-secondtime frame, the pulse count may be less than the desired count, and themotor may need to be driven in a counterclockwise direction to achievethe correct pulse count. Conversely, if the pulse count is larger thanthe target count, the next clockwise run may be purposefully reduced,and the correct count may be achieved by counterclockwise rotationwithin a 30-second time frame.

FIG. 18 b shows a simplified embodiment of one expected minimumcounterclockwise motor speed verses time. In this embodiment, a minimummotor pulse corresponds to 3.9 degrees of pump head rotation. At aminimum flow rate of 0.1 mL/hr the motor would pulse 30 times at 3.9°per pulse to rotate the pump head 117° per hour.

At the maximum flow rate of 1000 mL/hr the motor would rotate the pumphead 3250 revolutions per hour or 27 revolutions per 30 second pumpcycle. At the clockwise gear ratio the motor may be rotating at 5300rpm.

All of the concepts, devices and methods disclosed and claimed hereincan be made and executed without undue experimentation in light of thepresent disclosure. While the concepts, devices and methods of thisinvention have been described in terms of particular and preferredembodiments, it will be apparent to those of skill in the art thatvariations may be applied to the concepts, devices and methods and inthe steps or in the sequence of steps of the methods described hereinwithout departing from the concept, spirit and scope of the invention.More specifically, it will be apparent that certain components may besubstituted for the components described herein and the same or similarresults would be achieved. All such similar substitutes andmodifications apparent to those skilled in the art are deemed to bewithin the spirit, scope and concept of the invention as defined by theappended claims.

1. A method for delivering a plurality of medical fluids, the methodcomprising: fluidly interconnecting at least first and second medicalfluid delivery lines with one pump; first operating, during said fluidlyinterconnecting, said one pump to deliver a first medical liquid throughsaid first medical fluid delivery line; second operating, during saidfluidly interconnecting, said one pump to deliver a second medicalliquid through said second medical fluid delivery line in at leastnon-overlapping relation to said first operating step.
 2. The method ofclaim 1, wherein said fluidly interconnecting step comprises the stepsof: first interfacing a first valve interconnected with said firstmedical fluid delivery line with a first valve actuator; secondinterfacing a second valve interconnected with said second medical fluiddelivery line with a second valve actuator.
 3. The method of claim 2,further comprising: first positioning a valve controller from a firstcontroller position to a second controller position to actuate saidfirst valve actuator, wherein said second valve actuator remains in anon-actuated positioned during said first positioning.
 4. The method ofclaim 3, further comprising: second positioning a valve controller fromsaid second controller position to a third controller position toactuate said second valve actuator.
 5. The method of claim 3, furthercomprising: automatically returning, after said first positioning step,said first valve actuator to a non-actuated position.
 6. The method ofclaim 2 further comprising: actuating said first valve actuator.
 7. Themethod of claim 6, wherein said actuating step comprises: first moving avalve controller in a first direction; and driving, during said firstmoving step, said first valve actuator from a non-actuated position toan actuated position.
 8. The method of claim 7, wherein said actuatingstep comprises: second moving, prior to said first moving step, saidvalve controller in a second direction to position said valve controllerfor said first moving step.
 9. The method of claim 8, wherein duringsaid second moving step said second valve actuator is in a non-actuatedposition.
 10. The method of claim 8, wherein during both said firstmoving and second moving steps said second valve actuator is in anon-actuated position.
 11. The method of claim 6, wherein said actuatingstep occurs prior to said second operating step.
 12. The method of claim6, wherein said actuating said first valve controller step is a firstactuating, the method further comprising: second actuating said secondvalve actuator.
 13. The method of claim 2, wherein said firstinterfacing step comprises: relating said first valve to said firstvalve actuator by matching a color designation of said first valve to acolor designation of said first valve actuator.
 14. The method of claim2, further comprising: moving, prior to said fluidly interconnecting, acomponent of said one pump in linear response to an angular output of anangular element to enable placement of a medical fluid output linewithin said pump.